J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day be­fore Thanks­giv­ing, J&J’s Janssen has a new cut of Phase III Spra­va­to da­ta to be grate­ful for.

The phar­ma gi­ant an­nounced on Wednes­day that its nasal spray, al­so known as es­ke­t­a­mine, beat ex­tend­ed-re­lease que­ti­ap­ine, pre­vi­ous­ly sold by As­traZeneca as Sero­quel XR, in treat­ment-re­sis­tant de­pres­sion (TRD). Of 676 adults, a sig­nif­i­cant­ly high­er num­ber of pa­tients on Spra­va­to were able to achieve re­mis­sion and avoid re­lapse af­ter 32 weeks, ac­cord­ing to J&J.

Both drugs were ad­min­is­tered along­side a con­tin­ued se­lec­tive sero­tonin re­up­take in­hibitor (SS­RI) or sero­tonin and nor­ep­i­neph­rine re­up­take in­hibitor (SNRI), and pa­tients in the tri­al had failed on at least two oth­er treat­ments, in­clud­ing their on­go­ing ther­a­py.

At week 8, 27.1% of pa­tients in the Spra­va­to arm had achieved re­mis­sion, ac­cord­ing to J&J, com­pared to just 17.6% in the con­trol arm (p=0.003). Of those pa­tients who achieved re­mis­sion, 21.7% of Spra­va­to pa­tients were re­lapse-free at week 32, com­pared to 14.1% of con­trol pa­tients (p=0.008).

By week 32, about 55% of all Spra­va­to pa­tients had achieved re­mis­sion, com­pared to 37% of que­ti­ap­ine pa­tients (p<0.001), J&J re­port­ed.

Spra­va­to was first ap­proved for TRD back in 2019, lat­er ex­pand­ing the la­bel to ma­jor de­pres­sive dis­or­der in adults with acute sui­ci­dal ideation or be­hav­ior. How­ev­er, the drug quick­ly found it­self at the cen­ter of con­tro­ver­sy. De­spite get­ting an un­like­ly en­dorse­ment from for­mer Pres­i­dent Don­ald Trump for use by the VA, many pa­tients strug­gled to get ac­cess. Cost-ef­fec­tive­ness watch­dogs such as ICER and NICE have pre­vi­ous­ly crit­i­cized the price.

Just last week, Spra­va­to suf­fered yet an­oth­er re­jec­tion from NICE.

De­spite Janssen’s at­tempts to ap­peal pri­or NICE draft guid­ance, the agency said in a fi­nal ap­praisal doc­u­ment last week that it doesn’t rec­om­mend Spra­va­to for pa­tients with treat­ment-re­sis­tant de­pres­sion who’ve failed on at least two oth­er an­ti­de­pres­sants.

“The com­pa­ny po­si­tioned es­ke­t­a­mine nasal spray for peo­ple who have had at least 3 an­ti­de­pres­sants be­fore, with or with­out an­oth­er treat­ment like lithi­um or an an­tipsy­chot­ic med­i­cine. This is nar­row­er than the mar­ket­ing au­tho­ri­sa­tion, and al­so how clin­i­cal ex­perts ad­vised es­ke­t­a­mine would like­ly be used in NHS prac­tice,” NICE wrote.

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.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.