Janet Woodcock, acting FDA commissioner (AP Images)

Eli Lil­ly’s Covid-19 drug bam­lanivimab is no longer dis­trib­uted in 3 states be­cause of a vari­ant, Wood­cock says

The US gov­ern­ment is no longer dis­trib­ut­ing Eli Lil­ly’s bam­lanivimab in­to Cal­i­for­nia, Ari­zona and Neva­da be­cause of the preva­lence of a vi­ral vari­ant that is not sus­cep­ti­ble to the mon­o­clon­al an­ti­body, FDA act­ing com­mis­sion­er Janet Wood­cock told physi­cians tak­ing part in a we­bi­nar with the Amer­i­can Med­ical As­so­ci­a­tion on Wednes­day.

Wood­cock did not elab­o­rate fur­ther on the vari­ant or the de­ci­sion to halt the dis­tri­b­u­tion, but over­all, the FDA re­mains unique­ly po­si­tioned to screen the mon­o­clon­als against the dif­fer­ent vari­ants, Wood­cock added, and that’s been pre­dic­tive of how and where the treat­ments will work.

A Lil­ly spokesper­son told End­points News in a state­ment: “We rec­og­nize the U.S. gov­ern­ment has made the de­ci­sion to no longer al­low di­rect or­der­ing of bam­lanivimab alone in Cal­i­for­nia, Ari­zona and Neva­da due to con­cerns about the preva­lence of the ‘Cal­i­for­nia’ vari­ant, with the spe­cif­ic L452R sub­sti­tu­tion found in B.1.429/B.1.427 lin­eages (a.k.a. 20C/CAL.20C). Im­por­tant­ly, pre­clin­i­cal da­ta from our labs demon­strate that the com­bi­na­tion of bam­lanivimab and ete­se­vimab main­tains its neu­tral­iz­ing ef­fect against this vari­ant, specif­i­cal­ly.”

Over­all, Wood­cock ac­knowl­edged that the ini­tial roll­out of the mon­o­clon­al an­ti­bod­ies “wasn’t the great­est” be­cause it was cen­tered on a dis­tri­b­u­tion mod­el for Gilead’s an­tivi­ral remde­sivir, and “hos­pi­tals were in no po­si­tion to give out mon­o­clon­als.”

“We’re get­ting there but it’s tak­en quite a long time,” Wood­cock said in ref­er­ence to the mon­o­clon­al an­ti­bod­ies in the US. “Mass vac­ci­na­tion is hard enough but mass in­fu­sion is a re­al chal­lenge for our health care sys­tem.”

John Far­ley, di­rec­tor of the FDA’s of­fice of in­fec­tious dis­eases, said that the FDA ex­pects to soon broad­en the de­f­i­n­i­tion of who falls in­to the “high risk” cat­e­go­ry that de­ter­mines who can re­ceive the mon­o­clon­al an­ti­bod­ies.

“We know from the field that we would ben­e­fit by broad­en­ing this a bit and we’re ex­pect­ing to do that soon,” he said.

He al­so said that the three au­tho­rized mon­o­clon­al an­ti­bod­ies re­main ac­tive against the vari­ant orig­i­nat­ing in the UK, but there are “oth­er, more wor­ri­some vari­ants” and physi­cians should ex­pect to soon see more in­for­ma­tion on those.

As far as the wider ther­a­peu­tic land­scape for Covid-19, Wood­cock again not­ed the fact that just 5% of clin­i­cal tri­als for Covid-19 treat­ments were ad­e­quate­ly pow­ered and ran­dom­ized to pro­vide ac­tion­able da­ta.

“Low ac­cru­al rates and in­ad­e­quate pow­er mean that safe­ty and ef­fi­ca­cy da­ta will be un­in­ter­pretable,” she said. She al­so crit­i­cized the slow roll­out of the NIH-run tri­als for Covid-19 ther­a­peu­tics.

Over­all, she ex­plained some of the ma­jor chal­lenges that she saw as head of ther­a­peu­tics at Op­er­a­tion Warp Speed, and mov­ing for­ward, she dis­cussed what a ro­bust ecosys­tem for clin­i­cal tri­als in the US would look like.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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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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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”