Royalty Pharma said it has purchased additional royalties on Roche and PTC Therapeutics’ oral spinal muscular atrophy (SMA) drug for an upfront payment of $1 billion.
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The drug, GSBR-1290, belongs to the same class of treatments as Novo Nordisk’s blockbuster weight-loss drug Wegovy and Eli Lilly’s (LLY.N) diabetes drug Mounjaro.
The California pharma is building up to its first-ever approval with promising late-stage data for its once-daily investigational acromegaly pill paltusotine, an alternative to the injectable standard of care.
The FDA’s decision to decline the drug’s approval for a much larger cohort of patients with clinical depression, along with strict safety warnings for its use in PPD, is still a “strike against (Biogen’s) management”, Baird analyst Brian Skorney said.
Having access to an oral medication will be a beneficial option for many of women coping with PPD and having extreme, and sometimes life-threatening, feelings, says the FDA.
Canada has approved Amylyx Pharmaceuticals’ treatment for amyotrophic lateral sclerosis (ALS), a neurodegenerative disease, the first such approval for the oral drug. The decision came with certain conditions, including the release of data from its global late-stage study of about 600 patients, which is expected in 2024, as well as additional studies.