Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Gov­ern­ment gears for un­prece­dent­ed chal­lenge of Eli Lil­ly an­ti­body roll­out as ef­fi­ca­cy ques­tions linger

Af­ter months of an­tic­i­pa­tion, the FDA has au­tho­rized the first an­ti­body treat­ment for Covid-19. Now what?

The US gov­ern­ment faces a chal­lenge un­like vir­tu­al­ly any it has faced dur­ing or be­fore the pan­dem­ic. They will have to dis­trib­ute scarce quan­ti­ties of a much-sought drug through­out the coun­try at a time when cas­es are reach­ing record lev­els, over­bur­den­ing hos­pi­tals to the point where, in North Dako­ta, Covid-19 pos­i­tive nurs­es have been au­tho­rized to con­tin­ue work­ing.

The gov­ern­ment did not ini­tial­ly fare well last time it had to roll out a Covid-19 drug; in the spring, baf­fled doc­tors re­port­ed that hos­pi­tals with few Covid-19 pa­tients re­ceived pre­cious vials of remde­sivir, while those with many were over­looked. Dis­trib­ut­ing an an­ti­body pos­es an even greater chal­lenge, as it’s in­di­cat­ed for pa­tients with mild or mod­er­ate dis­ease — a much larg­er group of peo­ple, none of whom are al­ready in a hos­pi­tal, where an IV in­fu­sion can be eas­i­ly ad­min­is­tered.

On Tues­day, CDER chief Janet Wood­cock, who stepped away from the FDA to run the treat­ment arm of Op­er­a­tion Warp Speed, out­lined the gov­ern­ment’s plan to dis­trib­ute the 300,000 dos­es they’ve agreed to pur­chase from Eli Lil­ly. They will re­ly large­ly on a sys­tem that of­fi­cials even­tu­al­ly de­vel­oped for dis­trib­ut­ing remde­sivir: Rather than give the drug di­rect­ly to med­ical cen­ters, they will al­lo­cate it to states and ter­ri­to­ries ac­cord­ing to how many Covid-19 cas­es and hos­pi­tal­iza­tions they have. Lo­cal gov­ern­ments would then al­lo­cate it with­in their ju­ris­dic­tions.

For ex­am­ple, in the first al­lo­ca­tion this week, the large and hard-hit state of Texas will re­ceive 5,780 dos­es. Ver­mont, which is small and has kept the virus un­der rel­a­tive con­trol, will re­ceive 20.

Still, out­side ex­perts said that left key ques­tions unan­swered. Much of the coun­try still does not have enough test­ing ca­pac­i­ty to catch cas­es with­in the nar­row win­dow where ear­ly stud­ies in­di­cate the an­ti­body may be ben­e­fi­cial. And al­though au­thor­i­ties want to re­serve the drug for pa­tients who are at high risk, such as those with di­a­betes or obe­si­ty, that still leaves far more de­mand than sup­ply.

“In some pop­u­la­tions, you have half the peo­ple who will meet that high-risk cri­te­ria, so who you give it to and how you make that de­ci­sion isn’t clear,” said He­len Bouch­er, chief of in­fec­tious dis­eases at Tufts Med­ical Cen­ter in Boston, told The Wash­ing­ton Post. “The wor­ry is whether black and brown peo­ple get ac­cess who we know are be­ing dis­pro­por­tion­ate­ly af­fect­ed by this dis­ease.”

The dis­tri­b­u­tion will hap­pen while ques­tions linger about how ef­fec­tive the drug re­al­ly is. Al­though on­ly the medi­um, 2800 mg dose of the an­ti­body met the pri­ma­ry end­point of re­duc­ing vi­ral load in Lil­ly’s piv­otal tri­al, the FDA au­tho­rized a 700 mg dose and HHS is send­ing vials con­tain­ing that dose to the states.

The 700 mg dose will al­low them to give the drug to far more peo­ple, and Lil­ly says that all dos­es showed “sim­i­lar clin­i­cal ef­fects,” such as de­creas­ing the risk of hos­pi­tal­iza­tion and re­duc­ing symp­toms. Wood­cock de­fend­ed the gov­ern­ment’s de­ci­sion on a call with re­porters, point­ing to the da­ta Eli Lil­ly col­lect­ed on hos­pi­tal­iza­tion and symp­tom al­le­vi­a­tion.

She ar­gued that most peo­ple clear the virus on their own and that, among those who didn’t, all three dos­es of the drug re­duced vi­ral load. The p-val­ue for the 700 mg dose was 0.38.

“I think you are sort of ac­cept­ing a di­choto­mous view of p-val­ues,” she said, ac­cord­ing to Bio­Cen­tu­ry. “If you look at the vi­rol­o­gy da­ta, there was al­most no dif­fer­ence in virus clear­ance amongst the dif­fer­ent dos­es.”

For Wood­cock, the big­ger ques­tion is the roll­out. The gov­ern­ment is plan­ning to dis­trib­ute the an­ti­body in two phas­es, and even­tu­al­ly hopes to dis­trib­ute it, via states, to park­ing lot tents or trail­ers, which may be more ac­ces­si­ble. First, though, they’ll have to see if old-fash­ioned hos­pi­tals, ur­gent care cen­ters and ERs can do the trick.

“For the next two weeks, what we’re go­ing to be look­ing at very close­ly is the abil­i­ty of the health­care sys­tem to ac­tu­al­ly get this in­to peo­ple’s veins,” Wood­cock said.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: As­pen to pro­duce gener­ic J&J vac­cine for Africa; First boost­ers for un­der-18-year-olds could come next week — re­port

After some ups and downs surrounding the manufacturing of J&J’s Covid-19 vaccine as the South African company’s site, Aspen Pharmacare has announced an agreement with the pharma to make and sell an Aspen-branded Covid-19 vaccine through the continent.

The agreement will expand the already-existing tech transfer and agreement to give Aspen the right to make vaccines from drug substance supplied by J&J, and sell the finished form under the name Aspenovax to public sector markets in Africa.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.