FDA halts the use of GSK's Covid-19 drug com­plete­ly as BA.2 sub­vari­ant blan­kets the coun­try

It on­ly took the Omi­cron BA.2 sub­vari­ant three busi­ness days to go from shut­ting down Glax­o­SmithK­line and Vir Biotech­nol­o­gy’s Covid-19 treat­ment sotro­vimab in 22 states, as of last Fri­day, to the FDA com­plete­ly shut­ting off use of the mon­o­clon­al an­ti­body na­tion­wide on Tues­day af­ter­noon.

The de­ci­sion was made as the CDC now es­ti­mates that the pro­por­tion of Covid-19 cas­es caused by BA.2 is above 50% na­tion­wide.

“Sotro­vimab is no longer au­tho­rized to treat COVID-19 in any U.S. re­gion due to in­creas­es in the pro­por­tion of COVID-19 cas­es caused by the Omi­cron BA.2 sub-vari­ant,” the FDA said in a state­ment.

While Omi­cron and its sub­vari­ant haven’t strained the health sys­tem like pre­vi­ous vari­ants, at least so far, they have elim­i­nat­ed the use of sev­er­al key drugs from the US ar­ma­men­tar­i­um of Covid treat­ments.

But GSK and Vir made clear on Tues­day that sotro­vimab is far from done. In ad­di­tion to prepar­ing to sub­mit new da­ta to the FDA to sup­port a high­er dose of sotro­vimab to treat the BA.2 sub­vari­ant, the com­pa­nies are al­so still mov­ing ahead with their plans to sub­mit for a full FDA ap­proval for sotro­vimab in the sec­ond half of this year.

The pair al­so still ex­pect to man­u­fac­ture ap­prox­i­mate­ly 2 mil­lion dos­es in the first half of 2022, and ad­di­tion­al dos­es in the sec­ond half of the year.

They al­so still ex­pect to com­mence two Phase III tri­als this quar­ter, ac­cord­ing to a Vir SEC fil­ing, to as­sess the use of sotro­vimab in un­in­fect­ed im­muno­com­pro­mised pa­tients to de­ter­mine whether sotro­vimab can pre­vent symp­to­matic Covid in­fec­tion.

One tri­al is a plat­form tri­al, and the oth­er is a com­pa­ny-spon­sored tri­al, known as COMET-STAR, al­though the pri­ma­ry end­points for both are the in­ci­dence of symp­to­matic PCR-con­firmed Covid-19. Vir said COMET-STAR re­sults are still ex­pect­ed to come as ear­ly as the sec­ond half of this year, while ini­tial da­ta from the UK’s RE­COV­ERY Tri­al, which is eval­u­at­ing sotro­vimab among pa­tients hos­pi­tal­ized with Covid in the UK, is al­so ex­pect­ed in the sec­ond half of 2022.

But the loss of sotro­vimab right now in the US means the land­scape for Covid-19 treat­ments con­tin­ues to dwin­dle, with Eli Lil­ly’s bebtelovimab serv­ing as the last re­main­ing mAb.

Since last Sep­tem­ber, the US bought al­most $2 bil­lion worth of sotro­vimab cours­es, ac­cord­ing to BAR­DA, and shipped more than 912,000 cours­es to states (as of Sun­day), ac­cord­ing to the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse. Vir said it ex­pects to rec­og­nize over $1 bil­lion in sotro­vimab col­lab­o­ra­tion rev­enues in the first half of this year.

Three oth­er mAbs en­tered the grave­yard of Covid-19 treat­ments pre­vi­ous­ly as they were halt­ed due to wan­ing ef­fec­tive­ness against the dom­i­nant strain, in­clud­ing two block­busters from Eli Lil­ly (bam­lanivimab/ete­se­vimab and bam­lanivimab) and one block­buster com­bo mAb from Re­gen­eron (casiriv­imab/imde­vimab).

On the pos­i­tive side: More than $1 bil­lion of bebtelovimab has been ac­quired so far, and ear­ly da­ta sug­gest it will still stand up to BA.2.

On the neg­a­tive side: Con­gress has yet to fi­nal­ize ad­di­tion­al funds for ac­quir­ing more mAbs from Lil­ly, As­traZeneca’s pro­phy­lac­tic mAb, and an­tivi­ral pills from Pfiz­er and Mer­ck to treat Covid-19.

An agree­ment for $10 bil­lion in new funds has been agreed to in prin­ci­ple, but $5 bil­lion of that is like­ly de­vot­ed to pay­ing for the next round of Pfiz­er’s Paxlovid.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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FDA+ roundup: Leg­isla­tive asks for 2024 fo­cus on more au­thor­i­ties, gener­ic drug com­pe­ti­tion

The FDA’s legislative priorities for the next year highlight the agency’s focus on expanding generic drug competition, backstopping the supply chain and growing its current authorities.

On the new authorities front, FDA is seeking to expand its mandatory recall authority for all drugs, as the agency has been embroiled in a long process to remove some from the market. Covis Pharma refused to pull its preterm birth drug Makena, which won accelerated approval, for almost five years after failing its confirmatory trial. The company has since reversed course after a negative adcomm.

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