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.

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.

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.

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.”