Eli Lil­ly has clinched the first emer­gency use au­tho­riza­tion is­sued for an an­ti­body against Covid-19, set­ting in mo­tion a $1.2 bil­lion deal to sup­ply the feds with the drug — al­beit at a dose that failed the pri­ma­ry end­point in a key tri­al.

Pri­or­i­tiz­ing a re­duc­tion in Covid-19-re­lat­ed hos­pi­tal­iza­tions or vis­its to the ER, the FDA opened the door for physi­cians to give 700 mg/20 mL in­jec­tions of the drug, dubbed bam­lanivimab, to re­cen­ly di­ag­nosed, non-hos­pi­tal­ized pa­tients who don’t need ex­tra oxy­gen due to the coro­n­avirus in­fec­tion.

The emer­gency OK puts Lil­ly ahead of close ri­vals at Re­gen­eron, which an­nounced the EUA fil­ing for its an­ti­body cock­tail on the same day de­spite start­ing clin­i­cal tri­als slight­ly lat­er. That was al­so the day — Oc­to­ber 7 — Pres­i­dent Don­ald Trump de­clared with­out ev­i­dence he’s al­ready au­tho­rized the Re­gen­eron drug, which he re­ceived as part of his Covid-19 treat­ment.

In the EUA let­ter, FDA chief sci­en­tist Denise Hin­ton wrote the agency based its de­ci­sion on topline da­ta from the in­ter­im analy­sis of BLAZE-1 and con­clud­ed it is “rea­son­able to be­lieve that bam­lanivimab may be ef­fec­tive for the treat­ment of mild to mod­er­ate Covid-19” for pa­tients who are 12 or old­er, weigh at least 40 kg, and are at high risk of pro­gress­ing.

As is cus­tom­ary, she didn’t break down the ex­act num­bers reg­u­la­tors re­viewed. But an­a­lysts have been puz­zled by the lack of dose-de­pen­dent re­sponse in the Phase II tri­al: Out of three dos­es test­ed, on­ly the mid­dle, 2800 mg dose hit the pri­ma­ry end­point of re­duc­ing vi­ral load at sta­tis­ti­cal sig­nif­i­cance. The re­sults that Lil­ly re­cent­ly pub­lished in the New Eng­land Jour­nal of Med­i­cine raised fur­ther ques­tions about just how ef­fec­tive the low dose of bam­lanivimab is.

The 700 mg dose, mean­while, cut vi­ral lev­els by on­ly 0.20 com­pared to place­bo, for a p-val­ue of 0.38, far be­low the 0.05 thresh­old long con­sid­ered the in­dus­try stan­dard.

Lil­ly’s ar­gu­ment for ask­ing the FDA to au­tho­rize — and con­vinc­ing the feds to pur­chase — the low dose was that “sim­i­lar clin­i­cal ef­fects were seen across all dose lev­els,” which was the met­ric that mat­tered. In a new state­ment, CSO Daniel Skovron­sky high­light­ed that it ap­peared to re­duce Covid-re­lat­ed hos­pi­tal­iza­tions.

The FDA ap­par­ent­ly agreed with the com­pa­ny, not­ing in a press re­lease:

How­ev­er, the most im­por­tant ev­i­dence that bam­lanivimab may be ef­fec­tive came from the pre­de­fined sec­ondary end­point of COVID-19-re­lat­ed hos­pi­tal­iza­tions or emer­gency room vis­its with­in 28 days af­ter treat­ment. For pa­tients at high risk for dis­ease pro­gres­sion, hos­pi­tal­iza­tions and emer­gency room vis­its oc­curred in 3% of bam­lanivimab-treat­ed pa­tients on av­er­age com­pared to 10% in place­bo-treat­ed pa­tients. The ef­fects on vi­ral load and on re­duc­tion in hos­pi­tal­iza­tions and ER vis­its, and on safe­ty, were sim­i­lar in pa­tients re­ceiv­ing any of the three bam­lanivimab dos­es.

Go­ing with the low­er dose al­so meant that the same amount of drug ma­te­r­i­al could serve four times as many pa­tients as a 2800 mg reg­i­men could, a cru­cial dif­fer­ence giv­en lim­it­ed man­u­fac­tur­ing ca­pac­i­ty.

The an­ti­body for­mer­ly known as LY-CoV555 now joins con­va­les­cent plas­ma on the ros­ter of treat­ments with an EUA, with remde­sivir re­cent­ly grad­u­at­ing to full ap­proval sta­tus as Vek­lury.

HHS has agreed to pay $375 mil­lion for 300,000 vials of that dose, which it said is good for a 2-month sup­ply. The gov­ern­ment has an op­tion on an­oth­er 650,000 dos­es on the same terms, mean­ing $812 mil­lion more in po­ten­tial rev­enue for Lil­ly and Ab­Cellera, which orig­i­nal­ly de­vel­oped the drug in col­lab­o­ra­tion with the NIH.

The next step will be get­ting the man­u­fac­tur­ing in or­der af­ter in­spec­tors found qual­i­ty con­trol prob­lems at a New Jer­sey plant Lil­ly is us­ing to meet its goal of pro­duc­ing 1 mil­lion dos­es of the an­ti­body by year end.

Most of that will like­ly go to out­pa­tients af­ter the NI­AID shut­tered a study test­ing bam­lanivimab in com­bi­na­tion with remde­sivir for those hos­pi­tal­ized with Covid-19 , af­ter los­ing faith it could help sick­er pa­tients.

Lil­ly is al­so de­vel­op­ing a cock­tail that com­bines bam­lanivimab with ete­se­vimab from Jun­shi Bio­sciences, with a snap­shot of re­sults that had im­pressed com­men­ta­tors.

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

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.