Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
Receives regulatory approval for its molecule ‘Selumetinib’ in India
It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses
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