No­vo’s big re­veal: GLP-1 drug semaglu­tide cuts car­dio risks, but just may blind you

First, the good news for No­vo Nordisk’s di­a­betes drug semaglu­tide: The drug re­duced the num­ber of ma­jor car­dio events by 26% among high-risk pa­tients in a late-stage tri­al.

Now, the bad news: There was a sig­nif­i­cant spike in di­a­bet­ic retinopa­thy among pa­tients tak­ing semaglu­tide — with an un­ex­pect­ed­ly high­er rate of blind­ness — and they al­so dropped out of the drug arm at a faster pace.

The big num­ber that No­vo will fo­cus on as it preps for an ex­pect­ed ap­proval: 39%, which mea­sures a ma­jor re­duc­tion in the risk of stroke. There was al­so a drop in the rate of heart at­tacks in the drug arm, but re­searchers say that it wasn’t sta­tis­ti­cal­ly sig­nif­i­cant.

Add it all up and you have a da­ta set that No­vo will take to reg­u­la­tors with high ex­pec­ta­tions of an ap­proval, and a strong po­si­tion to pro­tect its big GLP-1 po­si­tion in the huge di­a­betes mar­ket. No­vo’s big drug, Vic­toza, has had to com­pete against once-week­ly Trulic­i­ty, but the phar­ma com­pa­ny is com­ing back with a more con­ve­nient dos­ing of its own now.

Vic­toza and Jar­diance, from Eli Lil­ly and Boehringer, have al­so both demon­strat­ed re­duced car­dio risks. And No­vo’s Mads Krogs­gaard Thom­sen tells Reuters that he’s plan­ning a longer tri­al for semaglu­tide which could put it in a po­si­tion to spell out the car­dio ad­van­tages on the la­bel.

The ma­jor play­ers in the di­a­betes mar­ket are known for duk­ing it out over every new R&D wrin­kle to come along. (That’s one fac­tor that pro­voked ear­ly skep­ti­cism for MannKind’s in­haled Afrez­za, which went un­part­nered un­til Sanofi came along — briefly — for a rocky ride in­to the mar­ket.) And No­vo is as com­pet­i­tive as any­one.

Thom­sen, ex­ec­u­tive vice pres­i­dent and chief sci­ence of­fi­cer of No­vo Nordisk, had this to say:

“The re­sults of SUS­TAIN 6 sup­port the strong po­ten­tial of once-week­ly semaglu­tide in type 2 di­a­betes treat­ment and we look for­ward to reg­u­la­to­ry sub­mis­sion lat­er this year. The SUS­TAIN 6 re­sults fur­ther strength­en the clin­i­cal ev­i­dence for the No­vo Nordisk GLP-1 re­cep­tor ag­o­nist port­fo­lio with the find­ing of ad­di­tion­al ben­e­fits be­yond gly­caemic con­trol and weight loss in adults with type 2 di­a­betes at high car­dio­vas­cu­lar risk.”

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Pharma industry groups like the Association for Accessible Medicines (AAM) and PhRMA are raising pointed questions about an FDA plan to create a new pathway for marketing prescription drugs with an additional condition for nonprescription use (ACNU), which would require more safeguards than the current OTC pathway but essentially carve out new OTC uses for some generic drugs.

Chief among the concerns were: Insurance companies dropping coverage for the Rx version, new ACNU patents to block competition, and industry essentially governing the pathway.

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Marc de Garidel, CinCor Pharma CEO (Eric Piermont/AFP via Getty Images)

Cin­Cor’s hy­per­ten­sion can­di­date flops a PhII test but plans to charge ahead with piv­otal study

Toward the end of summer, Massachusetts-based CinCor Pharma was riding high with a $225 million raise, touting a positive data readout. But a closer look under the hood has revealed a few hiccups in its Phase II.

CinCor on Monday unveiled topline results from its Phase II trial, dubbed HALO, evaluating baxdrostat in patients with uncontrolled hypertension who are taking up to two blood pressure medications. The trial whiffed on its primary endpoint of evaluating change from the “baseline in mean seated” systolic blood pressure (SBP) in the intent-to-treat population in all dosage levels.