Biogen B VBIIB

Biogen B V (BIIB) focuses on immunology, neurology, and psychiatry. The company's drug Zinbryta (daclizumab) for multiple sclerosis demonstrated an annualized relapse rate reduction of 54% versus placebo in Study 201 and 45% versus active control in Study 301. However, DAC-treated subjects experienced immune-mediated adverse events at an incidence of 30%, with serious DILI incidence at 0.9% and autoimmune hepatitis incidence at 7. Infections were observed in 4-5% of DAC-treated patients, with serious infections occurring 3 times more frequently than with Avonex or placebo. Other adverse events included dermatologic reactions in 40% of patients and non-infectious colitis-related events in 1.5% of subjects in Study 301.

Another product, Qalsody (tofersen), received an orphan medicinal product designation on 29 August 2016, with a marketing authorization application submitted on 31 October 2022. The CHMP issued a positive opinion on 22 February 2024, which was revised on 19 April 2024. Qalsody is recommended at a dose of 100 mg. In preclinical studies, tofersen reduced SOD1 mRNA in various tissues, with an ED50 of 93 µg in the cervical cord of SOD1-G93A rats and 48 µg in the lumbar cord of SOD1-G93A rats. In SOD1-G93A mice, tofersen at 300 µg extended median survival to 29.3 weeks compared to 24 weeks for control ASO.

Zuranolone (ZURZUVAE) is proposed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD), with a proposed treatment duration of 14 days. The drug acts as a GABAA positive allosteric modulator. In Study PPD-201B, irritability was observed in 1.3% of subjects. Sedation was reported in 11 subjects in Study PPD-301. The HAMD-17 response rate was 71.6% and the remission rate was 44.6% in the ROBIN (217-PPD-201) study. The relative infant dose of zuranolone in breast milk was 0.357%.