logo
Plus   Neg
Share
Email

Novartis Reports Positive CHMP Opinion For Gene Therapy To Treat Retinal Disease

Novartis (NVS) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for the approval of voretigene neparvovec, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene. Luxturna was developed and is marketed in the US by Spark Therapeutics. If approved, voretigene neparvovec will be commercialized by Novartis in markets outside the U.S.

Separately, the company announced the CHMP has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis. Gilenya was previously approved for adults with remitting forms of multiple sclerosis aged 18 years and older in Europe. The European Commission will review the CHMP opinion and is expected to deliver its final decision within three months.

Also, Sandoz, a Novartis division, announced the CHMP has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Video game retailer GameStop Corp. laid off more than 120 employees, or nearly 14 percent of the total workforce at its corporate headquarters and at some other offices, according to reports. The layoffs also include senior editorial staff at Game Informer, the company's print and digital publication. Some of the senior staff at Game Informer took to Twitter to announce about their layoffs. Uber Technologies Inc. will establish a new U.S. general and administrative hub in Dallas, which will create 3,000 new jobs and more than $75 million in capital investment, Texas Governor Gregg Abbott said. Uber will get a grant of $24 million from the Texas Enterprise Fund or TEF, a business incentive fund that is used for attracting new business to the state and to ensure their growth. SAMpark LLC recalled 185 Children's pajama sets for burn injury risk to children. The pajamas failed to meet the flammability standard for children's sleepwear that requires sleepwear to be either snug-fitting or flame resistant. However, there have been no incidents or injuries reported so far.
Follow RTT