FDA Approves STS101 for Acute Migraine, CALLIPER Trial Results Unveiled, Nipocalimab Gains FDA Approval for Myasthenia Gravis

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Welcome to this special edition of Neurology News Network. I'm Marco Meglio.

According to an announcement, the FDA has granted approval to Satsuma’s dihydroergotamine (DHE) nasal powder agent, STS101, marketed as Atzumi, as a new treatment for patients with acute migraine with or without aura. The company noted that the nasal powder is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. In addition, the most common adverse events (AEs) reported with the agent were rhinitis, nausea, altered sense of taste, application site reaction, dizziness, vomiting, somnolence, pharyngitis, and diarrhea.

Newly announced data from the phase 2 CALLIPER trial (NCT05054140) showed that treatment with investigational vidofludimus calcium (Immunic) led to a 20% risk reduction in confirmed disability worsening (CDW) events among patients with progressive multiple sclerosis (PMS) relative to placebo. In addition, the therapy was safe and led to modest benefits on the exploratory primary MRI end point of brain volume change, further supporting the therapy’s development in this patient population. CALLIPER was a double-blind, placebo-controlled exploratory study featuring patients with primary PMS (PPMS; n = 152) and non-active secondary PMS (naSPMS; n = 268) who received 45 mg daily doses of vidofludimus calcium or placebo for up to 120 weeks. All told, results revealed a 20% relative risk reduction of 24-week CDW events in the overall population, with an even greater effect observed in the PPMS group (30% reduction). Those with naSPMS also saw benefits from treatment, with a respective 15% reduction in comparison with placebo.

The FDA has approved Johnson & Johnson’s nipocalimab, marketed as Imaavy, as a new treatment for adults and pediatric patients aged 12 years and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive. Nipocalimab, an FcRn blocking therapy, is supplied as a 300 mg/1.62 mL and a 1200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection. Before starting treatment, patients are advised to talk to their healthcare provider if they have ever had an allergic reaction to nipocalimab, have or had any recent infections or symptoms of infection, have recently received or scheduled to receive an immunization, and are pregnant, planning to become pregnant, or are breastfeeding.

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