Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

Fi­bro­Gen will like­ly have to de­lay its US roll­out for rox­adu­s­tat once again.

In an un­ex­pect­ed move, the FDA is con­ven­ing its Car­dio­vas­cu­lar and Re­nal Drugs Ad­vi­so­ry Com­mit­tee to re­view the NDA in an ad­vi­so­ry com­mit­tee meet­ing. The date is yet to be con­firmed.

En­rique Con­ter­no

Just a few weeks ago, SVB Leerink an­a­lyst Ge­of­frey Porges pre­dict­ed that the roxa ap­proval could come ahead of the PDU­FA date on March 20 — ef­fu­sive de­spite al­ready be­ing let down once by the FDA’s ex­ten­sion of its re­view back in De­cem­ber. As­traZeneca, which is part­nered with Fi­bro­Gen on the chron­ic kid­ney dis­ease-re­lat­ed ane­mia drug, dis­closed reg­u­la­tors had re­quest­ed fur­ther clar­i­fy­ing analy­ses of clin­i­cal da­ta.

But the in­volve­ment of a “his­tor­i­cal­ly tough com­mit­tee,” Yaron Wer­ber of Cowen wrote, could weigh all of that down. And it did, with the stock $FGEN crash­ing 23.51% to $38.65.

“Man­age­ment con­firmed that rox­adu­s­tat’s NDA sub­mis­sion is of­fi­cial­ly be­ing re­viewed by the be­nign hema­tol­ogy de­part­ment and thus we as­sume this di­vi­sion has now sought out the CV/re­nal com­mit­tee pre­sum­ably to ad­dress some out­stand­ing risk/re­ward ques­tions about rox­adu­s­tat,” he not­ed. “His­tor­i­cal­ly, the CV/re­nal com­mit­tee has proven dif­fi­cult for ane­mia drugs, dic­tat­ing a no­tably high bar for safe­ty dur­ing sim­i­lar re­views for ESAs.”

Fi­bro­Gen has long tout­ed that by mim­ic­k­ing the ef­fect of high al­ti­tude, rox­adu­s­tat could stim­u­late the pro­duc­tion of red blood cells and in­crease he­mo­glo­bin lev­el with­out trig­ger­ing the car­dio­vas­cu­lar side ef­fects plagu­ing pa­tients tak­ing ery­thro­poiesis-stim­u­lat­ing agents, the cur­rent stan­dard of care.

But sub­se­quent da­ta re­leas­es stirred con­cerns about dif­fer­ences in non-dial­y­sis-de­pen­dent pa­tients, com­pared to dial­y­sis-de­pen­dent groups.

The key de­bate, ac­cord­ing to a re­cent Porges note, has al­ways been around the po­ten­tial of a black box warn­ing — and how far it would go.

Fi­bro­Gen CEO En­rique Con­ter­no “sug­gest­ed that the ex­tent of the black box warn­ing would in­flu­ence adop­tion in the NDD set­ting, which he re­it­er­at­ed is sev­er­al times the size of the DD mar­ket. In DD, he sug­gest­ed that the black box lan­guage shouldn’t have much im­pact on adop­tion, giv­en the la­bel­ing for ESAs and their near-uni­ver­sal use in that pop­u­la­tion.”

In a state­ment, Con­ter­no stood by the ef­fi­ca­cy and safe­ty pro­file of the drug, which is al­ready ap­proved in Chi­na, Japan and Chile.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.

How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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