FDA clears new ALS drug for US market
The FDA has approved Radicava in the US as the first new drug since 1995 to treat ALS. It will be marketed by MT Pharma America, a division of Mitsubishi Tanabe Pharma. Radicava’s US price is expected to be $145,000, significantly higher that its original price in Japan, which is about $35,000 per year. Radicava is given as a daily intravenous infusion for 14 days, followed by a 14-day gap. Subsequent treatment is dosing on 10 of 14 days, followed by 14-day gaps.
The approval of Radicava is the first for this rare disease since the FDA approved the disease-modifying agent Rilutek. While Radicava doesn’t affect the course of the disease, it slows symptoms and offers additional choices to patients.
