Sarep­ta crit­ic Jenk­ins is ex­it­ing the FDA, and Wood­cock takes di­rect charge of the OND af­ter a painful rup­ture

John Jenk­ins

A few weeks ago, John Jenk­ins, the long­time di­rec­tor of the FDA’s Of­fice of New Drugs, caused quite a stir with some ad­vice for biotechs to avoid the same reg­u­la­to­ry path­way adopt­ed by Sarep­ta, the new win­ner of a con­tro­ver­sial FDA ap­proval for Ex­ondys 51 for Duchenne mus­cu­lar dy­s­tro­phy.

“Path tak­en by Sarep­ta NOT a good mod­el for oth­er de­vel­op­ment pro­grams,” de­clared one of Jenk­ins’ talk­ing points un­der a fi­nal sec­tion marked “lessons learned” from eteplirsen and oth­er cas­es.

In the fu­ture, he not­ed in his pre­sen­ta­tion, de­vel­op­ers would be held to a high stan­dard when it came to new mar­ket­ing ap­provals; Sarep­ta was the ex­cep­tion that proved the rules. And any­one who thought about fol­low­ing Sarep­ta’s path at the FDA, he added, was go­ing down the wrong trail.

This morn­ing, though, CDER di­rec­tor and Sarep­ta cham­pi­on Janet Wood­cock spread the word that Jenk­ins is re­tir­ing from the FDA in ear­ly Jan­u­ary — and she’s tem­porar­i­ly as­sum­ing his po­si­tion.

Janet Wood­cock

“We will con­duct a na­tion­al search to fill John’s po­si­tion,” Wood­cock notes, af­ter a lengthy sum­ma­ry of his work at the agency. “Dur­ing this time of tran­si­tion, I will serve as act­ing di­rec­tor of OND. I will con­tin­ue to en­gage in dis­cus­sions with OND staff and work close­ly with OND lead­ers as we work to­geth­er to ad­dress sci­en­tif­ic ad­vances that will im­pact the new drug re­view pro­gram in the com­ing years.”

Jenk­ins’ de­par­ture comes af­ter a bru­tal show­down be­tween Wood­cock and top of­fi­cials at the FDA who fought hard against the ap­proval of Ex­ondys 51. Sarep­ta, its crit­ics say, nev­er came close to pro­vid­ing clear ev­i­dence of ef­fi­ca­cy and safe­ty for eteplirsen. But in the end, Com­mis­sion­er Robert Califf opt­ed to de­fer to the pow­er­ful Wood­cock, over­rul­ing the ob­jec­tions and deep split in­side the FDA about its role in su­per­vis­ing this ap­proval process.

Wood­cock has sig­naled her sup­port of tak­ing a more flex­i­ble ap­proach to drug ap­provals, leav­ing some tra­di­tion­al­ists aghast. But no mat­ter how peo­ple sided in the civ­il war that di­vid­ed reg­u­la­tors on Sarep­ta, there’s no doubt that Wood­cock’s al­ready con­sid­er­able clout at the FDA just grew by sev­er­al de­grees, leav­ing her in a po­si­tion to re­form the OND on her own terms as the FDA preps for the ar­rival of Don­ald Trump at the White House.

The most im­me­di­ate im­pact of Jenk­ins’ de­par­ture will be Wood­cock’s in­creased au­thor­i­ty at the FDA, says Michael Ga­ba, the fed­er­al pol­i­cy leader of the firm’s life sci­ences team at Hol­land & Knight. But the longterm fall­out may have pro­found im­pli­ca­tions for the bio­phar­ma busi­ness.

“There’s an in­ter­est­ing con­flu­ence of events tak­ing place that may very well shape the FDA’s fu­ture un­der the next Ad­min­is­tra­tion,” he notes in an email mes­sage. “I would agree that the Jenk­ins de­par­ture cer­tain­ly sig­nals a near-term con­sol­i­da­tion of Janet Wood­cock’s au­thor­i­ty at CDER. How that plays out will be a func­tion of who is se­lect­ed to serve as the next FDA Com­mis­sion­er.”

But, he adds, if the FDA al­lows more com­pa­nies to fol­low Sarep­ta’s lead, they could be set­ting the stage for a dam­ag­ing ero­sion of pub­lic con­fi­dence in the FDA — which the in­dus­try ben­e­fits from.

“I ex­pect that the op­po­si­tion ex­pressed by Jenk­ins and oth­ers with­in the FDA lead­er­ship around the Sarep­ta ap­proval will con­tin­ue among drug re­view­ers as they are bound to en­sure prod­ucts are safe and ef­fec­tive for their in­tend­ed use as sup­port­ed by sci­en­tif­ic da­ta,” Ga­ba adds. “And I think the drug in­dus­try has to be care­ful here. I can ap­pre­ci­ate that any one drug com­pa­ny may want to press its prod­uct through with fast track au­thor­i­ty when it can, and do so with the help of pa­tient ad­vo­cates. But as more drug de­vel­op­ers are suc­cess­ful in this man­ner, then the val­ue of an FDA ap­proval could very well be di­min­ished as post-mar­ket ad­verse events in­crease in the ab­sence of sol­id up-front end-point based sci­en­tif­ic da­ta. This could, over time I sus­pect, tar­nish the FDA’s ‘good house­keep­ing seal of ap­proval’ that in­dus­try as a whole should want to up­hold.”

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

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

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.