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Chinese regulatory agency approves Lucentis for treatment of wet AMD
BASEL, Switzerland — China's State Food and Drug Administration has approved Lucentis for the treatment of neovascular age-related macular degeneration, Novartis announced in a news release.
"Today's announcement demonstrates our continued commitment to providing patients in emerging markets access to innovative treatments where there is significant unmet need," David Epstein, head of the Pharmaceuticals Division at Novartis, said in the release.
Lucentis (ranibizumab, Novartis) is the first licensed medication in its class available in China. The drug's approval for the treatment of wet AMD is based on data from clinical studies conducted in China and other nations. It has become the standard of care in the treatment of wet AMD and has accrued more than 1 million patient-treatment years of exposure, according to the release.
Neovascular AMD affects approximately 300,000 new AMD patients annually in China, the release said.
"There is a huge unmet need for wet AMD patients in China, and we have been waiting for the Lucentis approval here since it was first launched in the United States in 2006," Xiaoxin Li, MD, chairman of the China Fundus Society, said. "We hope access to Lucentis will improve wet AMD patient treatment outcomes and optimize doctors' experiences."
Genentech holds commercial rights to Lucentis in the United States, and Novartis has exclusive rights in the rest of the world.