First oral postpartum depression drug approved

The FDA has approved a new, fast-acting medicine for postpartum depression made by Sage Therapeutics. But it rejected the company's bid to use its medicine in major depressive disorder, which would have represented a much larger market. The drug, called Zurzuvae, is meant to be taken orally for two weeks, and was able to maintain efficacy for another month. But the drug carries a boxed warning due to its sedative effects.

Clinical trials showed mixed results, particularly when it came to major depressive disorder — which is why the FDA likely nixed the drug for this larger indication. Sage and its partner, Biogen, are reviewing the FDA feedback to figure out the next steps. The data on postpartum depression were much stronger, leading to the approval.

Shares of Sage Therapeutics fell sharply in Monday's pre-market session. The company said it was "evaluating resource allocation" included potential employee layoffs, in order to cut costs and preserve cash.

Eye

FDA clears second drug for age-related vision loss

The FDA on Friday approved a second medicine for geographic atrophy, a progressive eye disease and a leading cause of blindness in older people. The monthly eye injection, called Izervay, was developed by Iveric Bio, recently acquired by Astellas.

Izervay enters the market six months after the FDA approved Syfovre, the first treatment for geographic atrophy made by Apellis Pharmaceuticals.

Recent reports of a small number of Syfovre patients losing vision due to severe eye inflammation have raised concerns about the drug's safety and hampered its commercial launch. Apellis has not yet found the cause of the rare side effect.

The FDA limited Izervay treatment to one year, although Astellas is expected to report two-year data next month.

cancer diagnostics

Dip in cancer screenings meant more late-stage diagnoses

Far fewer people showed up for cancer screenings during the first year of the pandemic than in the past — leading to a 20% decrease in early-stage cancer diagnoses. A new Lancet Oncology study shows that because of this disruption in care, patients became far more likely to be diagnosed with a deadly metastatic disease. A deep analysis using a nationwide registry that accounts for 70% of all cancers in the U.S. showed that diagnosing a stage 4 cancer was 7% more likely in 2020. Communities of color were particularly hard hit.

These numbers translate into stark realities for patients — and for hospital bottom lines. The drugs and interventions used to treat late-stage cancers are different than those for early-stage treatment — and diagnostic delays can lead to tens of thousands of additional patient deaths and tens of millions of dollars in added health care costs.

Biotech

After Covid windfall, a rough stretch for Pfizer

After a Covid-driven windfall, Pfizer is now struggling. Sales of the company's Covid drug and vaccine have plummeted, and shares are now down 31% year to date; Pfizer's valuation is down $144 billion since its peak in 2021. The company has made some acquisitions with the Covid fortune that it expects will pay off down the road, and plans to cut costs and some drug research programs. If Covid vaccines and drugs don't sell in the coming months, CEO Albert Bourla told the Wall Street Journal, he is prepared to trim R&D spending for Covid-19 and other disease areas.

"We are moving post-Covid," Bourla said.

The recent tornado that smashed into a North Carolina Pfizer plant hasn't helped matters. To help prevent the ongoing drug shortage problem, Pfizer is now consigning products made there to its emergencning ordering list, FiercePharma writes.

hobbies

E-commerce billionaire's biotech a 'social project'

Billionaire Hiroshi Mikitani is best known for founding the Japan-based e-commerce behemoth Rakuten, but he's become increasingly interested in biotech. These days, he's dedicating a fifth of his time to the sector, Bloomberg writes, particularly in the oncology space. His San Diego-based biotech, Rakuten Medical, uses light and immunotherapy drugs to treat cancer. He describes the company as a "social project" and isn't particularly focused on profitability — even though Rakuten Group as a whole is currently losing billions of dollars.

Rakuten Medical's approach was developed stateside at the National Cancer Institute, but has been approved since 2020 in Japan to treat inoperable or recurrent head and neck cancer. It's only been used in 300 patients. The infusion, called Akalux, is projected to have peak sales of $26.4 million by 2028. The modest sales don't mean much to Mikitiani: The biotech is something of a personal project for him, he said last week during an ASCO conference in Japan. Mikitiani first invested in the startup in 2013 while looking for a cure for his father, who had pancreatic cancer. He became its CEO in 2018, and Rakuten has invested at least $100 million in the venture.

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