Plus   Neg

Roche: FDA Extends Review Time For SMA Drug Risdiplam

Swiss drug maker Roche Group (RHHBY) announced Wednesday that the U.S. Food and Drug Administration has extended the review time for risdiplam for the treatment of spinal muscular atrophy or SMA.

In a statement, the company noted that the Prescription Drug User Fee Act or PDUFA date for FDA's review of the New Drug Application of risdiplam has been extended with a decision expected by August 24.

The extension is a result of the recent submission of additional data by Roche, including data from the pivotal SUNFISH Part 2 study, in close collaboration with the FDA.

In November 2019, the FDA granted Priority Review for risdiplam with a decision for approval expected by May 24. In February 2020, based on discussions with the FDA, Roche submitted additional data which could help ensure access to risdiplam for a broad range of people living with the condition, if approved. The FDA requires more time for review due to the volume of additional data submitted.

Roche has submitted filing applications for risdiplam in seven countries with submission in China imminent. Risdiplam is being investigated in infants, children and adults with Type 1, 2 or 3 SMA.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Tesla has cut prices of its electric cars in North America following a decline in auto demand during the coronavirus-induced lockdowns. The company is also reducing the prices for its vehicles in China. The luxury electric car maker has reduced the prices for its flagship Model S sedan and the Model X sport utility vehicle by $5,000 each. The U.S. Food and Drug Administration granted approval for Artesunate for Injection 110 mg, powder and solvent for solution to biopharmaceutical company Amivas (US), LLC as the only FDA-approved drug now in the U.S. for the first-line treatment of severe malaria in adult and pediatric patients. It is also the first FDA-approved product that Amivas has introduced to their commercial portfolio. Retail giant Walmart Inc. is entering the fashion resale market through its partnership with thredUP, an online consignment store for second-hand fashion and accessories. The deal will enable Walmart to expand its online fashion offerings. Walmart said that starting Wednesday, customers can browse nearly 750,000 pre-owned items across women's and children's clothing, accessories and footwear.
Follow RTT