Sweep­ing doubts aside, Eli Lil­ly beats Re­gen­eron to emer­gency OK — clear­ing low dose an­ti­body for quick roll­out

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.

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.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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 (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

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.