Glax­o­SmithK­line and Vir sub­mit Covid-19 mAb for emer­gency au­tho­riza­tion

As the US con­tin­ues to mon­i­tor the im­pact of vari­ants on au­tho­rized mon­o­clon­al an­ti­bod­ies (mAbs) and shake up which mAbs are dis­trib­uted where, Glax­o­SmithK­line and Vir Biotech­nol­o­gy said Fri­day that they’re seek­ing an emer­gency use au­tho­riza­tion for their own mAb.

The com­pa­nies are sub­mit­ting an ap­pli­ca­tion for their mAb, known as VIR-7831, as a treat­ment for adults and ado­les­cents (12 years and old­er) with mild-to-mod­er­ate Covid-19 who are at risk for pro­gres­sion to hos­pi­tal­iza­tion or death.

The sub­mis­sion is based on an in­ter­im analy­sis of ef­fi­ca­cy and safe­ty da­ta from a Phase III tri­al of 583 pa­tients, which demon­strat­ed an 85% (p=0.002) re­duc­tion in hos­pi­tal­iza­tion or death in those re­ceiv­ing VIR-7831 com­pared to place­bo. The tri­al’s In­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee rec­om­mend­ed that the tri­al stop en­roll­ment be­cause of the ear­ly sign of ef­fi­ca­cy.

The com­pa­ny al­so said the mAb may be pro­tec­tive against some of the cir­cu­lat­ing vari­ants. New in vit­ro da­ta pub­lished as a pre-print ear­li­er this month showed the mAb main­tains ac­tiv­i­ty against cur­rent vari­ants of con­cern orig­i­nat­ing in the UK, South Africa and Brazil. Ad­di­tion­al pre­clin­i­cal da­ta showed the mAb al­so ap­pears to main­tain ac­tiv­i­ty against the Cal­i­for­nia vari­ant, the com­pa­ny said.

The news of the sub­mis­sion comes as the US gov­ern­ment and Eli Lil­ly agreed to halt all dis­tri­b­u­tion of the com­pa­ny’s Covid-19 mon­o­clon­al an­ti­body bam­lanivimab as of Wednes­day due to the “sus­tained in­crease” of vari­ants in the US.

“We rec­og­nize the U.S. gov­ern­ment has made the de­ci­sion to no longer al­low di­rect or­der­ing of bam­lanivimab alone due to con­cerns about the preva­lence of the Cal­i­for­nia (B.1.427/B.1.429) and New York (B.1.526) vari­ants of SARS-CoV-2. The U.S. gov­ern­ment has en­abled di­rect or­der­ing of bam­lanivimab and ete­se­vimab to­geth­er as well as ete­se­vimab alone, to pair with bam­lanivimab that sites of care have on hand,” Lil­ly said.

Lil­ly is al­so spon­sor­ing an on­go­ing Phase 2 tri­al eval­u­at­ing VIR-7831 in the out­pa­tient set­ting in com­bi­na­tion with bam­lanivimab in low-risk adults with mild to mod­er­ate Covid-19.

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

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.