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FDA approves zuranolone for postpartum depression but issues complete response letter for major depressive disorder

Zuranolone molecule image from PubChem

FDA’s approval of Zurzuvae for PPD could mark a significant shift in the fight against postpartum depression (PPD). On August 4, the agency gave the green light for the oral medication, although it declined its use for major depressive disorder (MDD), citing insufficient evidence of effectiveness.

The former approval represents a milestone as the first ever FDA-authorized oral medication specifically for PPD, a condition estimated to affect one in five new mothers.

Still, the rejection for MDD, which affects more than 21 million American adults, sent Sage’s stock valuation reeling. In early afternoon trading, SAGE shares were down 52.24% to $17.24. In contrast, Biogen stock was up 0.47% to $270.19.

Sage’s optimism for Zurzuvae in PPD treatmentt

In a business update call, CEO Barry Greene attempted to accentuate the positive. “We&#…

Zuranolone could offer rapid relief from postpartum depression

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers.

“Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only made the situation worse.

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB) are optimistic about the prospects of zuranolone, a drug candidate for postpartum depression, that met primary and key secondary endpoints in the Phase 3 SKYLARK study. If approved, the drug would be the first oral therapy for postpartum depression.

The treatment response in the placebo-controlled study was “robust,” Meltzer-Brody said.

Patients two received a 50 mg daily dose of zuranolone, a neuroactive steroid, had a 15.6 reduction in the 17-item Hamilton Rating Scale for Depression (HAM-…

Sage Therapeutics and Biogen formally pursue FDA approval for zuranolone for depression

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD).

The two companies plan on submitting additional clinical data for the NDA in the second half of the year.

Biogen entered into a $1.5 billion licensing agreement with Sage Therapeutics to commercialize zuranolone (SAGE-217) and SAGE-324 in late 2020.

Zuranolone is an oral neuroactive steroid GABA-A receptor positive allosteric modulator (PAM).

In Phase 3 clinical trials, zuranolone 50 mg is administered daily for 14 days.

In addition to MDD, Sage and Biogen plan on pursuing approval for zuranolone in PPD starting next year.

The drug candidate won Fast Track Designation from the FDA in 2017 in MDD and Breakthrough Therapy Designation a year later.

Data were positive from the LANDSCAPE and NEST clinical trial programs.

“Zuranolone has the p…

Zuranolone shows promise in treating postpartum depression

Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression.

The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.

After a 15-day treatment period, the zuranolone group had a mean change in HAM-D score of −17.8, resulting in a final mean score of 11.0, which is the normal range. Meanwhile, the −13.6 change in the placebo group results in a final mean score of 14.8, indicating mild-to-moderate depression.

For context, in the HAM-D system, a score of 10–13 indicates mild depression. The range of 14–17 represents mild to moderate depression. A score higher than 17 indicates severe depression.

[Related: Biogen bets $1.5B on Sage Therapeutics’ n…

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top:

Get the full story from our sister site, Drug Discovery & Development.

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Here are the 10 companies that came in on top.

Get the full story from our sister site, Drug Discovery & Development.

And browse data on all the Pharma 50 companies here.

10 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries.

To get a sense of which pharmaceutical companies in the sector were the best employers, we sifted through data on company reviews sites Glassdoor and Comparably, and other sources.

Below are the 10 companies that came in on top. (And browse data on all the Pharma 50 companies here.)

1. Sage Therapeutics

Glassdoor rating: 4.4/5 83% would recommend to a friend

Pros: Workers at Sage Therapeutics applauded the company’s work-life balance and culture. Just under three-quarters (74%) had a positive business outlook for the firm. One recent reviewer found meaning in “doing the toughest job in the world by developing CNS drugs.” The company’s brain health p…

Amylyx hires new CFO

Amylyx Pharmaceuticals, a company dedicated to developing new treatments for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), will install James Frates as chief financial officer (CFO) on Jan. 25, 2021. Frates has currently worked as the CFO of the global biopharma company Alkermes (NSDQ: ALKS) since 1998.

“We are so excited for Jim to join us at this critical juncture for Amylyx,” said Joshua Cohen, co-CEO and co-founder of Cambridge, Mass.-based Amylyx, in a statement. “Jim’s depth and breadth of experience as a biopharmaceutical executive coupled with his financial acumen and personal mission for bringing promising treatments to patients with ALS make him a fantastic addition to our leadership team.”

“Jim brings the unique combination of experience with growing biopharma companies focused on the central nervous system, both as a CFO and a board member, and passion for the people we serve,” said Justin Klee, co-CEO and co-founder of Am…