FDA Ad­Com backs Gilead­'s move to ex­pand De­scovy la­bel — but stops short of en­dors­ing broad PrEP use

Gilead is one step clos­er to un­lock­ing a po­ten­tial­ly block­buster new use of its two-drug HIV reg­i­men De­scovy — though prob­a­bly not all of it.

In a meet­ing late Wednes­day, the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 16 to 2 en­dors­ing De­scovy as a pre-ex­po­sure pro­phy­lax­is, or PrEP, in men and trans­gen­der women who have sex with men. On the ques­tion of ex­pand­ing the in­di­ca­tion to in­clude cis­gen­der women, though, a slight ma­jor­i­ty of ex­perts (10 ver­sus 8) vot­ed against it, cit­ing a lack of da­ta.

Di­ana Brainard

The rec­om­men­da­tions were large­ly in line with the agency’s in-house re­view, which point­ed out that an ap­proval cov­er­ing cis­gen­der women would re­quire a ques­tion­able ex­trap­o­la­tion of PK da­ta. While Gilead did pro­vide proof of sys­temic drug con­cen­tra­tions, the mea­sure­ments were large­ly un­help­ful in quan­tifi­able and in­ter­pret­ing whether there are ad­e­quate drug con­cen­tra­tions in cer­vi­co­v­agi­nal tis­sues.

In a state­ment, Di­ana Brainard — SVP of HIV and emerg­ing virus­es — praised the Ad­Com for a “thought­ful re­view and dis­cus­sion of the da­ta.” Though the com­pa­ny did not com­ment di­rect­ly on ex­pand­ing De­scovy’s use to cis­gen­der women, it had this to add:

Gilead rec­og­nizes the val­ue that De­scovy could bring to HIV pre­ven­tion ef­forts for the broad­est pos­si­ble at-risk pop­u­la­tion in the Unit­ed States and will con­tin­ue to work with FDA as the agency com­pletes its re­view of the ap­pli­ca­tion.

In terms of seiz­ing a big piece of the mar­ket, though, miss­ing out on the cis­gen­der women la­bel might not be that big of a deal af­ter all. Cis­gen­der women form less than 7% of PrEP use, ac­cord­ing to Jef­feries an­a­lyst Michael Yee.

SVB Leerink’s Ge­of­frey Porges not­ed just a few days ago that MSMs form the most im­por­tant pop­u­la­tion for De­scovy’s add-on OK, though “for Gilead’s pur­pos­es it is use­ful to have a broad la­bel with all rel­e­vant at-risk pop­u­la­tions in­clud­ed, and get­ting such an en­dorse­ment from the Ad­Com would give their De­scovy launch ad­di­tion­al mo­men­tum.”

His peak sales es­ti­mate for De­scovy stands at $3.8 bil­lion.

Ad­di­tion­al mo­men­tum mat­ters here be­cause De­scovy will like­ly be go­ing up against gener­ics of Gilead’s own Tru­va­da, with launch­es sched­uled for next Sep­tem­ber. De­scovy’s ad­van­tages over Tru­va­da — sub­sti­tut­ing TAF, or teno­fovir alafe­namide, for TDF (teno­fovir diso­prox­il fu­marate) in com­bi­na­tion with emtric­itabine — could ap­pear slight un­der the best of cir­cum­stances. It re­mains to be seen whether pay­ers will be will­ing to cov­er a new brand­ed drug over a gener­ic for safe­ty is­sues such as bone min­er­al den­si­ty.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Per­cep­tive fields SPAC #3 as an­oth­er group of biotechs scoops up $364M in lat­est Nas­daq romp

There’s no sign that the windfall of cash dropping biotech’s way on Wall Street is abating. Three more biopharmas priced IPOs on Thursday and Friday morning, riding a historic boom with a $364 million payoff.

London-based biotech Freeline Therapeutics took home the lion’s share of the cash with $159 million after pricing 8,823,529 shares at $18 a pop. Checkmate Pharmaceuticals, of Cambridge, MA, raised $75 million with an offer of 5 million shares at $15 — right at the midpoint of its range. And Arya Sciences Acquisition Corp III, the third in a series from Perceptive, priced 13,000,000 shares at $10 per share.

President Trump (AP Images)

UP­DAT­ED: FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as phar­ma warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.