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Celgene files NDA for Revlimid in Japan

Celgene has filed a New Drug Application with the Japanese Ministry of Health, Labour and Welfare for Revlimid in combination with dexamethasone

Celgene has filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy.

The application follows two large, randomised pivotal phase III special protocol assessment trials, published in the New England Journal of Medicine in November 2007. A phase I study including Japanese patients confirmed similar safety and efficacy results.

Around 4,000 people are diagnosed with multiple myeloma in Japan each year.

"The filing of an NDA in Japan for multiple myeloma represents an important step towards achieving our goal of delivering Revlimid to patients in need in one of the world's largest oncology populations," said Joseph Melillo, general manager of Celgene.

Revlimid in combination with dexamethasone is approved for the treatment of multiple myeloma in patients who have received at least one prior therapy in nearly 50 countries.

The drug has received significant coverage in the news in the UK and was the subject of a recent BBC documentary The Price of Life aired on June 17. The National Institute for Health and Clinical Excellence (NICE) recommended Revlimid for use on the NHS in combination with dexamethasone for the treatment of multiple myeloma only in patients who have received two or more prior therapies.

9th July 2009

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