The suc­cess of mon­o­clon­al an­ti­body (mAb) cock­tails in keep­ing peo­ple with Covid-19 out of the hos­pi­tal con­tin­ued Tues­day, with Re­gen­eron an­nounc­ing that even a low­er-than-au­tho­rized dose of its com­bi­na­tion of mAbs re­duced hos­pi­tal­iza­tion or death by 70% in non-hos­pi­tal­ized Covid-19 pa­tients.

George Yan­copou­los

“We will rapid­ly dis­cuss the new da­ta with reg­u­la­to­ry au­thor­i­ties and re­quest that the 1,200 mg dose be added to the U.S. Emer­gency Use Au­tho­riza­tion, in or­der for the an­tic­i­pat­ed RE­GEN-COV sup­ply to be avail­able to treat even more pa­tients,” George Yan­copou­los, pres­i­dent and CSO of Re­gen­eron, said in a state­ment.

The place­bo-con­trolled tri­al of more than 4,500 peo­ple showed how casiriv­imab and imde­vimab re­duced the risk of hos­pi­tal­iza­tion or death by 70% for the 1,200 mg IV dose, and 71% for the au­tho­rized 2,400 mg IV ver­sion, when com­pared to place­bo, the com­pa­ny said.

In ad­di­tion, Re­gen­eron said a dose-rang­ing Phase II tri­al of 815 non-hos­pi­tal­ized Covid-19 pa­tients showed “sig­nif­i­cant and com­pa­ra­ble vi­ral re­duc­tions” for all dos­es test­ed of the mAb com­bo, in­clud­ing as low as 300 mg. A com­pa­ny spokesper­son said fur­ther dis­cus­sions with the FDA will be nec­es­sary to dis­cuss sub­cu­ta­neous ad­min­is­tra­tion, and “even low­er dose pos­si­bil­i­ties in the fu­ture.”

Walid Gel­lad

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, who’s un­af­fil­i­at­ed with the re­sults, said that they show yet an­oth­er ex­am­ple of how ef­fec­tive these mAbs are for out­pa­tient use to re­duce hos­pi­tal­iza­tion.

“Com­pa­nies in a pan­dem­ic should be ap­plaud­ed for test­ing low­er dos­es, which will ex­tend sup­ply,” he added.

De­spite the pos­i­tive new da­ta, dos­es of the Re­gen­eron and Eli Lil­ly mAb cock­tails have been dif­fi­cult to come by and states have had to grap­ple with fig­ur­ing out new ways to ad­min­is­ter the in­fu­sions.

A Re­gen­eron spokesper­son said the com­pa­ny so far has de­liv­ered near­ly 300,000 dos­es to the US (al­though the gov­ern­ment’s web­site still says it’s dis­trib­uted about 150,000 as of ear­ly Feb­ru­ary). Be­gin­ning in April, Re­gen­eron will de­liv­er sup­plies of the mAb cock­tail un­der its sec­ond con­tract with the US gov­ern­ment, which will pro­vide 750,000 or more dos­es by mid-year.

“Most re­cent­ly we have said we ex­pect to pro­vide ap­prox­i­mate­ly 750,000 dos­es at the 2,400 mg dose lev­el by June 30, but now we an­tic­i­pate be­ing able to pro­vide more if the 1,200 mg dose is added to the EUA,” the spokesper­son added.

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.

Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.

A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

While both Pfizer/BioNTech and Moderna are looking to administer boosters for their Covid-19 vaccines six months after the initial two-dose series, J&J — which has vaccinated about 15 million Americans so far with its one-shot vaccine — is taking a more unique approach with boosters.

According to briefing documents released ahead of Friday’s FDA adcomm on the booster dose, J&J is calling for its boosters to be administered anywhere from two months to six months following the initial shot, depending on the strength of the immune responses.