FDA spells out how the Covid-19 vari­ants im­pact the ef­fec­tive­ness of Re­gen­eron, Eli Lil­ly mAb treat­ments

The FDA on Thurs­day af­ter­noon up­dat­ed its three fact sheets on the mon­o­clon­al an­ti­body treat­ments from Eli Lil­ly and Re­gen­eron, of­fer­ing new da­ta on the sus­cep­ti­bil­i­ty of the SARS-CoV-2 vari­ants orig­i­nat­ing in the UK, Brazil, South Africa, Cal­i­for­nia and New York to each of the mAb ther­a­pies.

“Some vari­ants can cause re­sis­tance to one or more of the mAb ther­a­pies au­tho­rized to treat COVID-19,” FDA said. “Health care providers should re­view the au­tho­rized fact sheets for in­for­ma­tion on the use of the au­tho­rized mAb ther­a­pies against cur­rent­ly cir­cu­lat­ing vi­ral vari­ants.”

For Lil­ly’s bam­lanivimab alone, which is no longer be­ing dis­trib­uted by the US gov­ern­ment in Cal­i­for­nia, Neva­da and Ari­zona be­cause of the vari­ant orig­i­nat­ing in Cal­i­for­nia, the FDA not­ed in its re­vised fact sheet ma­jor re­duc­tions in sus­cep­ti­bil­i­ty for all of the vari­ants stud­ied, ex­cept for the one orig­i­nat­ing in the UK. Al­most 800,000 cours­es of bam­lanivimab have now been dis­trib­uted across the US, in­clud­ing more than 100,000 cours­es to Cal­i­for­nia, Neva­da and Ari­zona.

But for Lil­ly’s com­bi­na­tion ther­a­py of bam­lanivimab and ete­se­vimab, the up­dat­ed fact sheet showed the treat­ment fared bet­ter against all of the vari­ants than bam­lanivimab alone. A Lil­ly spokesper­son said in a state­ment: “It has al­ways been our view that ad­di­tion­al an­ti­bod­ies from Lil­ly and oth­ers will need to be de­vel­oped to ad­dress the evo­lu­tion of the virus, in­clud­ing emerg­ing vari­ants that can dif­fer by coun­try or even by state. In fact, this is what drove our work on bam­lanivimab and ete­se­vimab to­geth­er and con­tin­ues to un­der­pin our strat­e­gy mov­ing for­ward.”

And Re­gen­eron’s mAb com­bi­na­tion of casiriv­imab with imde­vimab showed the least re­duc­tion in sus­cep­ti­bil­i­ty against the vari­ants, ac­cord­ing to its up­dat­ed fact sheet. Through Feb. 2, the US says it’s al­lo­cat­ed 148,022 dos­es of the Re­gen­eron mAb cock­tail.

“FDA is re­quired to reg­u­lar­ly re­view the cir­cum­stances and ap­pro­pri­ate­ness of an EUA, and the agency con­tin­ues to re­view emerg­ing sci­en­tif­ic in­for­ma­tion as­so­ci­at­ed with the emer­gency us­es for the au­tho­rized mAb prod­ucts, in­clud­ing in­for­ma­tion on vi­ral vari­ants,” the agency said in a state­ment. “FDA is com­mit­ted to pro­vid­ing up­dat­ed in­for­ma­tion on vari­ants and their po­ten­tial im­pact on the au­tho­rized mAb ther­a­pies as new in­for­ma­tion be­comes avail­able.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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