FDA plots mul­ti-day hear­ing to re­view 'dan­gling' ac­cel­er­at­ed ap­proval that drug­mak­er re­fus­es to pull

What hap­pens when the FDA tells a com­pa­ny to pull a drug ap­proved un­der its ac­cel­er­at­ed path­way be­cause it didn’t prove to be ef­fec­tive in a con­fir­ma­to­ry tri­al, and the com­pa­ny re­fus­es?

Celia Wit­ten

That’s what is cur­rent­ly play­ing out be­tween the FDA and Co­vis Phar­ma, which will du­el it out dur­ing a fi­nal two-and-a-half-day vir­tu­al hear­ing set for next Sep­tem­ber or Oc­to­ber, ac­cord­ing to the lat­est let­ter from Celia Wit­ten, FDA’s di­rec­tor of the Of­fice of Cel­lu­lar, Tis­sue and Gene Ther­a­py and who’s pre­sid­ing over the hear­ing.

It’s been al­most 18 months since the FDA rec­om­mend­ed that Co­vis Phar­ma with­draw its con­tro­ver­sial drug Mak­e­na, and still the drug, which first won an ac­cel­er­at­ed ap­proval in 2011 but failed a con­fir­ma­to­ry tri­al in 2018, re­mains on the mar­ket.

In a show of fair­ness, the hear­ing will al­low for both Co­vis and FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search to each make two-hour pre­sen­ta­tions, and both CDER and Co­vis will be giv­en a full hour to ask ques­tions af­ter the op­pos­ing side makes its pre­sen­ta­tion. An ad­di­tion­al four hours will be set aside for pub­lic com­ments, which will al­low for the gener­ic man­u­fac­tur­ers of Mak­e­na to al­so speak.

“I must af­ford CDER and Co­vis an op­por­tu­ni­ty to ask ques­tions af­ter pre­sen­ta­tions by the pub­lic and re­serve time for the ad­vi­so­ry com­mit­tee mem­bers and me to do so, as well,” Wit­ten wrote to at­tor­neys from both CDER and Co­vis. The third day (a half day) will al­low for clos­ing state­ments from both sides.

CDER said pre­vi­ous­ly that Co­vis should not be al­lowed to present in­fo on oth­er ac­cel­er­at­ed ap­provals at the hear­ing, but Wit­ten wrote that she’ll al­low it to a cer­tain de­gree, ex­plain­ing:

I will not pro­hib­it Co­vis from ref­er­enc­ing oth­er prod­ucts grant­ed ac­cel­er­at­ed ap­proval as a means of shap­ing and fram­ing its ar­gu­ments and pre­sen­ta­tion at the hear­ing, though I en­cour­age Co­vis to keep ref­er­ences to oth­er prod­ucts brief be­cause any time spent dis­cussing oth­er prod­ucts grant­ed ac­cel­er­at­ed ap­proval will take time away from Co­vis’s pre­sen­ta­tion on more per­ti­nent and fun­da­men­tal is­sues at the hear­ing.

How­ev­er, Wit­ten makes clear that the de­sign of any fu­ture con­fir­ma­to­ry tri­al(s) is not an is­sue to be de­cid­ed as part of this hear­ing process.

And while CDER’s lawyer pre­vi­ous­ly pushed back on the idea of us­ing re­al-world ev­i­dence to sup­port the case of Mak­e­na, Wit­ten said she’ll al­low Co­vis to present such da­ta as “the avail­abil­i­ty and fea­si­bil­i­ty of cer­tain study de­signs in light of ex­ist­ing da­ta and in­for­ma­tion re­gard­ing Mak­e­na’s ef­fec­tive­ness might have some rel­e­vance in de­ter­min­ing whether FDA should with­draw ap­proval while ad­di­tion­al con­fir­ma­to­ry stud­ies are con­duct­ed.”

Francesco Tal­lari­co, gen­er­al coun­sel at Co­vis, told End­points News via email that the com­pa­ny is not re­fus­ing the FDA’s re­jec­tion de­ci­sion but that:

“The agency de­ter­mined, based on the sci­en­tif­ic da­ta pre­sent­ed by Co­vis, that a hear­ing re­quest was jus­ti­fied due to the ex­is­tence of ‘spe­cif­ic chal­lenges to the fac­tu­al and sci­en­tif­ic bases un­der­ly­ing CDER’s pro­pos­al’ and ‘gen­uine and sub­stan­tial is­sues of fact ap­pro­pri­ate for a hear­ing.’ The FDA was not re­quired to grant a hear­ing but did so based on an in­de­pen­dent re­view of the ev­i­dence pre­sent­ed by the com­pa­ny.”

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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