FDA Grants AstraZeneca’s Selumetinib Orphan Drug Status for Treatment of Uveal Melanoma –Update
Source: Nasdaq, April 2015
LONDON–AstraZeneca PLC’s (AZN.LN) selumetinib drug has been granted a special status by the U.S. Food and Drug Administration for treatment of Uveal melanoma, a rare eye disease.
The biopharmaceutical firm said Friday the FDA has granted ‘Orphan’ drug status to selumetinib for the treatment of Uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye.
The ‘Orphan’ status is granted to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S.
AstraZeneca acquired exclusive worldwide rights to selumetinib from Array BioPharma Inc in 2003.
Selumetinib, inhibits the MEK pathway — a chain of communication proteins — in cancer cells to prevent the tumor from growing.
AstraZeneca also said Friday that data from a phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year.
In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type 1, the company added.
At 1005 GMT AstraZeneca shares traded up 9 pence, or 0.1% higher, at GBP48.43, valuing the FTSE 100 pharmaceutical company at GBP61.15 billion.