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10 August, 2022
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1. Major drug price reforms head for Biden's signature as PhRMA weighs legal options
2. Senate Dems cling to a simple majority to pass some of the biggest drug pricing reforms ever
3. With drug pricing almost done, Congress looks to wrap up FDA user fee legislation
4. Hoping to expand monkeypox vaccine supply, US paves the way for new route of administration
5. CDC, NIH, FDA leaders call for US-based clinical trial of smallpox drug in treating monkeypox
6. US to stop supplying Lilly's mAb for Covid-19 this month as commercial market awaits
7. To avoid shortage of Merck's diabetes drug, FDA allows higher impurity levels temporarily
8. FDA's vaccine adcomm to review first fecal transplant to treat C. difficile infections
9. Civica, Mayo Clinic and others sound off on FDA draft guidance to mitigate drug shortages
10. CorMedix hit with second CRL for antifungal treatment, citing manufacturing and API issues
11. Reata’s ‘regulatory concerns’ turn into three-month delay on FDA decision for Friedreich’s ataxia drug
more stories
 
Zachary Brennan
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Be sure to check out Lei Lei Wu’s expert webinar tomorrow on non-opioid pain drug R&D and the litany of failures — register here.

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Zachary Brennan
Senior Editor, Endpoints News
@ZacharyBrennan
President Joe Biden (AP Images)
1
by Zachary Brennan

The fact that the new drug price ne­go­ti­a­tions for cer­tain block­buster Medicare drugs — due for a par­ti­san thumbs up in the US House of Rep­re­sen­ta­tives on Fri­day and a sig­na­ture from Pres­i­dent Joe Biden soon af­ter — don't take ef­fect un­til 2026 means there'll be plen­ty of time for PhRMA and oth­ers in bio­phar­ma to weigh their le­gal op­tions.

But what PhRMA or any bio­phar­ma com­pa­ny may po­ten­tial­ly sue over will be the key, as le­gal ex­perts point to the com­pli­cat­ed ne­go­ti­a­tions side of the rec­on­cil­i­a­tion bill, which be­gin­ning in 2026 would kick off these price con­ces­sions for 10 of the most ex­pen­sive sin­gle-source drugs in Medicare's Part D pro­gram, build­ing up to about 60 drugs from both Part D and B by 2030, with prices gen­er­al­ly capped by at least 40%.

Con­sid­er­able at­ten­tion by Con­gress has been paid to small­er com­pa­nies and drugs and bi­o­log­ics with im­pend­ing com­pe­ti­tion. For in­stance, in 2029 and 2030, there would be a max­i­mum fair price floor of 66% of the av­er­age non-FAMP for small biotech com­pa­nies' bi­o­log­ics (com­pared to 75% for most drugs that have been on the mar­ket for less than 12 years), ac­cord­ing to the law firm Hogan Lovells.

Still, if man­u­fac­tur­ers fail or de­cline to com­ply with the ne­go­ti­a­tion process, they would be sub­ject to a sig­nif­i­cant ex­cise tax (build­ing up from 65% of a drug's sales to 95%), which is a stick so large that it could po­ten­tial­ly run afoul of the ex­ces­sive fines clause of the Eighth Amend­ment of the Con­sti­tu­tion, le­gal ex­perts said.

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2
by Zachary Brennan

The Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­i­ca — and their fleet of drug in­dus­try lob­by­ists on Capi­tol Hill — are known for nev­er los­ing.

When­ev­er a big drug pric­ing bill comes up, an army of the in­dus­try group's lob­by­ists de­scend on­to the Hill and ei­ther smash it out­right or dis­man­tle it piece by piece.

But for per­haps the largest drug pric­ing re­forms ever en­act­ed, af­ter more than a decade of Con­gress try­ing and fail­ing to al­low Medicare to ne­go­ti­ate pre­scrip­tion drug prices, those same lob­by­ists and their bio­phar­ma clients were dealt a stun­ning blow on Sun­day af­ter­noon.

Sen­ate De­moc­rats sal­vaged all 50 of their seats (plus Vice Pres­i­dent Ka­mala Har­ris to break the tie) to hold off Re­pub­li­can amend­ments af­ter more than a dozen hours of overnight vot­ing to pass a wider-rang­ing tax and cli­mate bill.

The win for the Sen­ate Dems, tee­ing up an­oth­er par­ti­san thumbs-up vote in the House this Fri­day and a guar­an­teed Pres­i­dent Joe Biden sig­na­ture, means that for the first time ever, the fed­er­al gov­ern­ment will be able to ne­go­ti­ate and/or set prices on some of the most ex­pen­sive drugs that, via its Cen­ters for Medicare and Med­ic­aid Ser­vices, it pays for.

The bill al­so caps se­niors’ out-of-pock­et spend­ing for pre­scrip­tion drugs at $2,000 per year — a his­toric move as some se­niors on cer­tain treat­ments spend up­wards of $2,000 per month on their drugs.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)
3
by Zachary Brennan

The Sen­ate won't re­turn from its sum­mer re­cess un­til Sept. 6, but when it does, it of­fi­cial­ly has 18 busi­ness days to fi­nal­ize the reau­tho­riza­tion of the FDA user fee pro­grams for the next 5 years, or else thou­sands of drug and bi­o­log­ics re­view­ers will be laid off and PDU­FA dates will van­ish in the in­ter­im.

FDA com­mis­sion­er Rob Califf re­cent­ly sent agency staff a memo ex­plain­ing how, "Our lat­est es­ti­mates are that we have car­ry­over for PDU­FA , the user fee fund­ing pro­gram that will run out of fund­ing first, to cov­er on­ly about 5 weeks in­to the next fis­cal year."

That means Con­gress has a tiny cush­ion of about a month, un­til Nov. 4, to get its act to­geth­er.

Right now, there are vast dif­fer­ences be­tween the House-passed ver­sion of the bill from ear­ly June, and the Sen­ate's pre­vi­ous­ly in­tro­duced ver­sion, which it has yet to vote on. While there are dif­fer­ences be­tween the two ver­sions, on ma­jor is­sues like the reg­u­la­tion of IVDs and cos­met­ics, both the House and Sen­ate agree that ac­cel­er­at­ed ap­proval path­way re­forms should be added to the user fee deals.

But in­dus­try and oth­ers are mak­ing the case for not go­ing too far with those re­forms, es­pe­cial­ly as ac­cel­er­at­ed ap­provals have helped many can­cer pa­tients ac­cess treat­ments ear­li­er than they oth­er­wise would have.

Am­gen re­searchers re­cent­ly pub­lished a pa­per ex­plain­ing, "Over the 30-year his­to­ry of the ac­cel­er­at­ed ap­proval pro­gram, there have been rel­a­tive­ly few delin­quent cas­es or dan­gling ap­provals. Leg­isla­tive or oth­er changes to the pro­gram should be based on cu­mu­la­tive ex­pe­ri­ence, not out­liers."

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4
by Nicole DeFeudis

Af­ter mak­ing it clear that the US’ cur­rent mon­key­pox vac­cine sup­ply is in­suf­fi­cient, the FDA on Tues­day au­tho­rized a new route of ad­min­is­tra­tion that should in­crease the num­ber of avail­able dos­es by five-fold.

Reg­u­la­tors cleared Bavar­i­an Nordic’s Jyn­neos vac­cine for in­tra­der­mal in­jec­tion in adults old­er than 18. Un­like sub­cu­ta­neous in­jec­tion — the cur­rent method by which vac­cine is de­liv­ered un­der the skin — an in­tra­der­mal jab goes di­rect­ly in­to the skin. It’s be­lieved that this method re­quires less vac­cine, since the der­mis is rich in den­drit­ic cells which spe­cial­ize in tak­ing up for­eign anti­gens and pre­sent­ing them to the im­mune sys­tem, ac­cord­ing to Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston.

“In re­cent weeks the mon­key­pox virus has con­tin­ued to spread at a rate that has made it clear our cur­rent vac­cine sup­ply will not meet the cur­rent de­mand,” FDA com­mis­sion­er Robert Califf said in a news re­lease.

The news comes as the New York Times re­ports that about 20 mil­lion dos­es of the vac­cine have ex­pired in the US na­tion­al stock­pile.

The down­side to in­tra­der­mal in­jec­tion? It’s more dif­fi­cult to per­form cor­rect­ly, William Schaffn­er, a pro­fes­sor in Van­der­bilt Uni­ver­si­ty’s in­fec­tious dis­eases di­vi­sion, told End­points News on Tues­day.

As Schaffn­er put it, in­tra­der­mal in­jec­tion is “a bit of an art form.” It was most com­mon­ly used for tu­ber­cu­lo­sis skin tests; how­ev­er, he not­ed that it’s like­ly the av­er­age nurse now may have nev­er giv­en an in­tra­der­mal in­oc­u­la­tion, or on­ly had brief ex­po­sure. It’s much eas­i­er to stick a nee­dle through the skin for a sub­cu­ta­neous in­jec­tion.

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5
by Kyle LaHucik

With the ris­ing num­ber of mon­key­pox cas­es, lead­ing re­searchers at the CDC, FDA and NIH are call­ing on a ran­dom­ized clin­i­cal tri­al to see if an ap­proved small­pox drug is ef­fec­tive at treat­ing mon­key­pox.

No mon­key­pox treat­ments are ap­proved in the US, so pa­tients look­ing to get re­lief for their le­sions and oth­er symp­toms from the virus must go through a set of hur­dles to get the small­pox drug through a gov­ern­ment ex­pand­ed ac­cess pro­gram. Ap­proved for small­pox in 2018, the drug is mar­ket­ed as TPOXX by the biotech SIGA. The Eu­ro­pean Union ap­proved it for mon­key­pox in ad­di­tion to small­pox ear­li­er this year and the UK fol­lowed suit in Ju­ly.

In an opin­ion piece pub­lished in the New Eng­land Jour­nal of Med­i­cine on Wednes­day, gov­ern­ment re­searchers said the NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases is work­ing with the AIDS Clin­i­cal Tri­als Group, which has over­seen stud­ies of HIV meds since the 1980s, to set up a clin­i­cal tri­al to test TPOXX for mon­key­pox.

But while NI­AID, ACTG and SIGA all con­firmed to End­points News via email that a US-based clin­i­cal tri­al of the drug is be­ing planned, they de­clined to say when it would start. Ac­tivists ar­gue the tri­al should have tak­en place be­fore mon­key­pox be­came a glob­al out­break be­cause the virus has been en­dem­ic in some coun­tries in Africa for years.

“Adults with mon­key­pox in­fec­tion, in­clud­ing peo­ple liv­ing with HIV, would be el­i­gi­ble to en­roll. NI­AID will share more in­for­ma­tion as it be­comes avail­able,” the NI­AID said in an emailed state­ment.

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6
by Zachary Brennan

Fed­er­al of­fi­cials said yes­ter­day that ship­ments of Eli Lil­ly's bebtelovimab — one of the fi­nal two re­main­ing mAb treat­ments for Covid-19 — would halt lat­er this month, set­ting up a com­mer­cial mar­ket where the gov­ern­ment no longer pays for the dos­es and hos­pi­tals and oth­er clin­ics will have to pur­chase sup­plies.

Ac­cord­ing to AS­PR, the arm of HHS that ships Covid-19 drugs, states have or­dered 627,536 bebtelovimab cours­es, and 383,515 cours­es have been ad­min­is­tered as of Ju­ly 31. The US has paid Lil­ly a to­tal of about $1.27 bil­lion for all of the cours­es so far, amount­ing to about $2,100 per course to start and then re­ceiv­ing a dis­count­ed $1,833 ASP for the lat­er part of the deal. Ac­cord­ing to the Wall Street Jour­nal, Lil­ly’s list price for bebtelovimab is $2,100 per dose.

“I don’t an­tic­i­pate that this will in any way stim­u­late us­age of the prod­uct,” Dan Skovron­sky, Lil­ly’s chief sci­en­tif­ic and med­ical of­fi­cer, told WSJ in an in­ter­view. “It’s more just about, how do we keep it avail­able de­spite the U.S. gov­ern­ment not be­ing able to pur­chase it any­more. That’s why we’re switch­ing to a dif­fer­ent mod­el here.”

On Fri­day, the FDA up­dat­ed the bebtelovimab Let­ter of Au­tho­riza­tion to re­move the re­quire­ment that dis­tri­b­u­tion will be con­trolled by the US gov­ern­ment.

Lil­ly said it will make bebtelovimab com­mer­cial­ly avail­able for pur­chase by US states/ter­ri­to­ries, hos­pi­tals and a broad set of oth­er providers like in­fu­sion cen­ters, long-term care fa­cil­i­ties, and clin­ics through Amerisource­Ber­gen Spe­cial­ty Dis­tri­b­u­tion, the sole dis­trib­u­tor be­gin­ning the week of Aug. 15.

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7
by Zachary Brennan

The FDA said Tues­day that it re­cent­ly be­came aware of a ni­trosamine im­pu­ri­ty, Ni­troso-STG-19 or NTTP, in cer­tain sam­ples of Mer­ck­'s type 2 di­a­betes drug Janu­via.

To avoid a short­age of the drug that pulled in more than $10.5 bil­lion for Mer­ck in 2020 and 2021, and to help en­sure pa­tients have ac­cess to an ad­e­quate sup­ply, the FDA said it will not ob­ject to the tem­po­rary dis­tri­b­u­tion of sitagliptin con­tain­ing the im­pu­ri­ty above the ac­cept­able in­take lim­it.

Typ­i­cal­ly, if a drug con­tains lev­els of ni­trosamines above the ac­cept­able dai­ly in­take lim­it, the FDA rec­om­mends the man­u­fac­tur­er con­duct a re­call.

"Sitagliptin is a pre­scrip­tion drug used to con­trol high blood sug­ar in pa­tients with type 2 di­a­betes mel­li­tus. It could be dan­ger­ous for pa­tients with this con­di­tion to stop tak­ing their sitagliptin with­out first talk­ing to their health care pro­fes­sion­al. FDA rec­om­mends pre­scribers con­tin­ue to use sitagliptin when clin­i­cal­ly ap­pro­pri­ate to pre­vent a gap in pa­tient treat­ment," the agency said.

The FDA al­so said it will de­ter­mine on a case-by-case ba­sis whether drugs should be re­leased for dis­tri­b­u­tion. NTTP be­longs to a class of po­ten­tial­ly can­cer-caus­ing ni­trosamine com­pounds, de­tect­ed via lab­o­ra­to­ry tests.

"Al­though there are no da­ta avail­able to di­rect­ly eval­u­ate the car­cino­genic po­ten­tial of NTTP, FDA used in­for­ma­tion avail­able on close­ly re­lat­ed ni­trosamine com­pounds to cal­cu­late life­time ex­po­sure lim­its for NTTP," the agency said. "Agency sci­en­tists eval­u­at­ed the risk of ex­po­sure to NTTP at in­ter­im ac­cept­able in­take lev­els up to 246.7 ng per day and de­ter­mined that it presents min­i­mal ad­di­tion­al can­cer risk when com­pared to a life­time of ex­po­sure to NTTP at the 37 ng per day lev­el."

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8
by Zachary Brennan

Back in 2018, Swiss drug­mak­er Fer­ring Phar­ma­ceu­ti­cals made a big bet on Min­neso­ta-based Re­bi­otix, buy­ing up the com­pa­ny for its ex­per­i­men­tal poop-based drug im­plant to treat an in­fec­tion caused by C. dif­fi­cile, a po­ten­tial­ly dan­ger­ous bac­te­ria, in a new way.

Four years lat­er, Fer­ring's fe­cal mi­cro­bio­ta trans­plant, dubbed RBX2660 or Re­by­ota, will face the FDA's ad­comm of out­side vac­cine ex­perts on Sept. 22, de­bat­ing whether the agency should li­cense the trans­plant as a treat­ment for adults fol­low­ing an­tibi­ot­ic treat­ment for re­cur­rent C. dif­fi­cile in­fec­tion.

Back in May, Fer­ring an­nounced that a Phase III, place­bo-con­trolled tri­al with about 600 par­tic­i­pants showed that RBX2660 demon­strat­ed su­pe­ri­or ef­fi­ca­cy ver­sus place­bo (70.4% and 58.1%, re­spec­tive­ly) at eight weeks post-treat­ment, with a com­pa­ra­ble safe­ty pro­file to place­bo.

Al­ready grant­ed fast track, or­phan, and break­through ther­a­py des­ig­na­tions from the FDA, RBX2660's piv­otal Phase III re­sults build on near­ly a decade of re­search on the mi­cro­bio­me da­ta col­lect­ed over six con­trolled clin­i­cal tri­als with more than 1,000 par­tic­i­pants, Re­bi­otix said in a state­ment.

But pri­or to that Phase III an­nounce­ment, the FDA in June 2019 (up­dat­ed in March 2020) raised con­cerns of the po­ten­tial risk of se­ri­ous or life-threat­en­ing in­fec­tions with the use of fe­cal mi­cro­bio­ta for trans­plan­ta­tion.

Two im­muno­com­pro­mised adults who re­ceived in­ves­ti­ga­tion­al FMT de­vel­oped in­va­sive in­fec­tions caused by ex­tend­ed-spec­trum be­ta-lac­ta­mase (ES­BL)-pro­duc­ing Es­cherichia coli (E. coli), and one of the in­di­vid­u­als died, the FDA said.

But Fer­ring said in a state­ment that it does­n't have any de­tails on the pa­tients men­tioned in the FDA's safe­ty alert, as they were not en­rolled in the com­pa­ny's clin­i­cal tri­als.

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9
by Tyler Patchen

Sev­er­al phar­ma groups are lay­ing out the pos­i­tives and neg­a­tives of new FDA draft guid­ance on how best to han­dle drug short­ages.

The draft is in­tend­ed to help com­pa­nies de­vel­op and im­ple­ment risk man­age­ment plans (RMPs) to as­sist with any short­ages of drugs or bi­o­log­ics. The guid­ance rec­om­mends a frame­work and fac­tors for stake­hold­ers to de­vel­op RMPs for their es­tab­lish­ments, API man­u­fac­tur­ers and oth­ers.

Civi­ca, a gov­ern­ment-fund­ed non­prof­it aim­ing to re­duce chron­ic drug short­ages, com­ment­ed along­side the Mayo Clin­ic and San­ford Health — all gen­er­al­ly sup­port­ing RMPs. How­ev­er, they say there is an op­por­tu­ni­ty to pre­vent or mit­i­gate short­ages by im­prov­ing up­on in­ven­to­ry man­age­ment once sup­ply dis­rup­tion is iden­ti­fied.

“Cur­rent­ly, health sys­tems gen­er­al­ly learn about a drug short­age once the prod­uct be­comes un­avail­able, which may be weeks or months af­ter the man­u­fac­tur­er sup­ply dis­rup­tion has be­come known to the FDA. If health sys­tems know about short­ages soon­er, it may be able to ad­just uti­liza­tion, such as by us­ing the drug on­ly when nec­es­sary or switch­ing to al­ter­na­tive prod­ucts for suit­able pa­tients, for ex­am­ple, us­ing an oral med­ica­tion in­stead of an in­jectable,” the com­ment said.

The health sys­tems can im­ple­ment waste re­duc­tion strate­gies or repack­age the con­tents of vials to al­low for use to treat mul­ti­ple pa­tients if a short­age were to oc­cur, they obe­serve. But for them to be ef­fec­tive, ear­ly de­tec­tion is key.

The com­ment rec­om­mends that drug dis­trib­u­tors have a plan in place im­me­di­ate­ly to put a drug on al­lo­ca­tion when no­ti­fied by the FDA of a po­ten­tial im­pend­ing short­age.

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Joe Todisco, CorMedix CEO
10
by Tyler Patchen

Fol­low­ing a C-suite shuf­fle, a shut­ter­ing of its Eu­ro­pean op­er­a­tions and a CRL for its treat­ment to pre­vent blood­stream in­fec­tions in pa­tients un­der­go­ing chron­ic he­modial­y­sis, CorMedix is still not im­press­ing the FDA.

The biotech has now been giv­en a sec­ond re­jec­tion let­ter, as the NDA sur­round­ing its an­ti­fun­gal so­lu­tion, De­fen­Cath, can­not be ap­proved un­til is­sues sur­round­ing its con­tract man­u­fac­tur­ing or­ga­ni­za­tion and the sup­pli­er of the API he­parin dur­ing in­spec­tions are re­solved, CorMedix said Mon­day af­ter­noon.

While CorMedix has been work­ing with its third-par­ty man­u­fac­tur­er to cor­rect any prob­lems, it has still not been cleared to go ahead with the NDA.

Sep­a­rate­ly, the FDA al­so in­spect­ed the fa­cil­i­ty of the com­pa­ny’s he­parin sup­pli­er. This led to a warn­ing let­ter for the API sup­pli­er for hav­ing man­u­fac­tur­ing de­fi­cien­cies for a non-he­parin API. Though the sup­pli­er has re­tained an in­de­pen­dent con­sul­tant to cor­rect the prob­lems, they could not be re­solved be­fore the PDU­FA date.

As a re­sult of these is­sues, CorMedix has now sought an­oth­er CMO in Al­ca­mi Cor­po­ra­tion and is in the process of hav­ing its tech trans­ferred over. CorMedix is al­so get­ting its sup­ply of he­parin from an­oth­er al­ter­na­tive source as well. CorMedix now ex­pects to send its NDA back around the first quar­ter of next year.

“While I am dis­ap­point­ed that we will not re­ceive FDA ap­proval for the NDA on our PDU­FA date, I am en­cour­aged to have sub­stan­tive la­bel­ing and clin­i­cal re­view com­plet­ed by FDA and I am con­fi­dent there is a line of sight to FDA ap­proval of the NDA, once ei­ther our ex­ist­ing CMO and API sup­pli­er ob­tain com­pli­ance clear­ance, or we are able to sub­mit and ob­tain reg­u­la­to­ry ap­proval for man­u­fac­tur­ing at Al­ca­mi,” said CorMedix CEO Joe Todis­co in a state­ment.

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Warren Huff, Reata Pharmaceuticals CEO
11
by Lei Lei Wu

In its Q2 re­port Mon­day, Rea­ta Phar­ma­ceu­ti­cals said that the FDA con­tin­ues to have con­cerns about its Friedre­ich’s atax­ia drug.

On Tues­day, those con­cerns man­i­fest­ed in a three-month de­lay on an FDA ap­proval de­ci­sion. Rea­ta’s new FDA de­ci­sion dead­line for its Friedre­ich’s atax­ia drug, omavelox­olone, is the end of Feb­ru­ary 2023, it an­nounced this morn­ing.

In the Q2 re­port, Rea­ta not­ed that the FDA was con­cerned about the ef­fi­ca­cy of omavelox­olone. The Plano, TX-based biotech said that in re­sponse to those con­cerns, it sub­mit­ted ad­di­tion­al da­ta from its clin­i­cal tri­al. But in or­der to re­view that new da­ta, the FDA needs more time, hence the three-month de­lay, Rea­ta said Tues­day morn­ing.

Friedre­ich’s atax­ia is a rare ge­net­ic dis­ease in which nerve fibers de­gen­er­ate over time. In 2019, Rea­ta sur­prised an­a­lysts with a pos­i­tive read­out on its piv­otal omavelox­olone tri­al. How­ev­er, that ini­tial buzz died a year lat­er when the FDA said the sup­ple­men­tal da­ta Rea­ta sub­mit­ted on its piv­otal tri­al was not enough, re­quest­ing that the biotech run an ad­di­tion­al tri­al.

Rea­ta’s stock RE­TA dropped around 30% Mon­day morn­ing in re­ac­tion to the news of an­oth­er de­lay on the drug.

While there is cur­rent­ly no ap­proved treat­ment for Friedre­ich’s atax­ia, the few biotechs that have gone af­ter the in­di­ca­tion haven’t seen much suc­cess. In 2016, Hori­zon’s $50k/month drug Ac­tim­mune, al­ready ap­proved for two oth­er in­di­ca­tions, flunked a Phase III tri­al for Friedre­ich’s atax­ia. And Lari­mar Ther­a­peu­tics’ Phase I pro­gram has been on clin­i­cal hold af­ter non-hu­man pri­mates died in pre­clin­i­cal test­ing.

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