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
Kolcraft Enterprises Inc. has recalled inclined sleeper accessory sold with certain sleepers to prevent suffocation risk, the U.S. Consumer Product Safety Commission said. The Chicago, Illinois-based company called back the products after reports of infant fatalities due to other manufacturers' inclined sleep products. Casino operator MGM Resorts International said it was the victim of a data breach in 2019 after a report claimed that the details of more than 10.6 million hotel guests were exposed. Technology website ZDNet reported about the incident late on Wednesday, saying that the personal details of more than 10.6 guests who stayed at MGM Resorts hotels were published on a hacking forum this week. Amid the ongoing troubles with its 737 MAX commercial planes grounding since March 2019, Boeing (BA) has secured a five-year U.S. Air Force contract to sustain and modernize the Global Decision Support System, or GDSS. The financial terms of the deal were not disclosed. The contract was awarded to Tapestry Solutions, part of Boeing Global Services.
Follow RTT
>