J&J pro­pos­es slid­ing boost­er time­lines as FDA ques­tions lack of da­ta for Delta, old­er adults be­fore ad­comm

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.

“The need for a boost­er dose and/or its tim­ing will de­pend on the lo­cal/epi­demi­o­log­i­cal sit­u­a­tion and the needs of in­di­vid­u­als/spe­cif­ic pop­u­la­tions,” J&J said.

In FDA’s brief­ing doc­u­ment, the agency did not take a stand on whether this slid­ing in­ter­val for a boost­er would be ad­e­quate, but the agency did sug­gest, with caveats, there may be some ben­e­fit when a boost­er is ad­min­is­tered just two months af­ter the pri­ma­ry shot.

“Al­though not in­de­pen­dent­ly con­firmed by FDA from datasets, sum­maries of the da­ta sug­gest there may be a ben­e­fit in a sec­ond dose ad­min­is­tered ap­prox­i­mate­ly 2 months af­ter the pri­ma­ry dose, when com­pared to the ef­fi­ca­cy seen in the piv­otal study,” the agency said.

How­ev­er, con­fi­dence in­ter­vals around the ef­fi­ca­cy es­ti­mates for a sin­gle dose vs. two dos­es over­lap, FDA says, adding:

Ad­di­tion­al­ly, the small sam­ple size cas­es in in­di­vid­u­als 60 years of age and old­er lim­its the abil­i­ty to con­clude about an in­crease in ef­fi­ca­cy af­ter the sec­ond dose in this group. Fi­nal­ly, the small num­ber of ac­crued cas­es con­firmed to be caused by the Delta vari­ant pre­cludes any con­clu­sion re­gard­ing ef­fi­ca­cy against that vari­ant.

But on the safe­ty end, sim­i­lar­ly to what FDA said with Mod­er­na, re­view of safe­ty analy­ses fol­low­ing a sec­ond dose (2-month in­ter­val) among sev­er­al thou­sand re­cip­i­ents with a me­di­an blind­ed fol­low-up of 36 days “do not iden­ti­fy in­creased re­ac­to­genic­i­ty or new safe­ty con­cerns com­pared with the safe­ty pro­file of the sin­gle dose; how­ev­er, post-au­tho­riza­tion sur­veil­lance will be need­ed to fur­ther eval­u­ate and quan­ti­fy the risk of un­com­mon but med­ical­ly im­por­tant ad­verse re­ac­tions.”

The FDA al­so made clear that the mR­NA vac­cines are su­pe­ri­or in terms of ef­fi­ca­cy to the J&J shot:

Over­all, da­ta in­di­cate that the Janssen COVID-19 Vac­cine still af­fords pro­tec­tion against se­vere COVID-19 dis­ease and death in the Unit­ed States, al­though the high­est ef­fec­tive­ness es­ti­mates (in­clud­ing for more se­vere COVID-19 dis­ease) across clin­i­cal tri­als and re­al-world ef­fec­tive­ness stud­ies eval­u­at­ing the Janssen COVID-19 Vac­cine are con­sis­tent­ly less than the high­est ef­fec­tive­ness es­ti­mates for the mR­NA COVID-19 vac­cines.

FDA’s VRB­PAC will meet to­mor­row and Fri­day to dis­cuss the safe­ty and ef­fi­ca­cy of the Mod­er­na and J&J boost­ers.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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John Evans, Beam Therapeutics CEO

Beam's base-edit­ed al­lo­gene­ic CAR-T gets FDA go-ahead af­ter four-month wait

The FDA wanted more information on four key areas before it would let Beam Therapeutics proceed with human testing for a cell therapy in a certain type of leukemia. It appears the biotech has answered the agency’s queries.

The US regulator cleared the base-edited, off-the-shelf CAR-T, Beam said Friday morning, lifting a hold from this summer. More details on specific next steps for the Phase I will come out next year, the Boston-area biotech said.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.