Amgen's Repatha India Trial Waiver Plan Trips Up
Amgen's PCSK9 inhibitor Repatha, already constrained by payor pushbacks on prices in the West and awaiting outcomes data, now appears to be facing a challenge in India. A key Indian expert panel has turned down Amgen's request for a trial waiver for evolocumab, a move that could hold up launch plans with partner Dr Reddy's.
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Amgen is building on its alliance with Dr. Reddy’s Laboratories in India, shifting out certain products previously sold by GlaxoSmithKline in the country to the Hyderabad-based firm.
In a very strong second-quarter earnings report, Amgen reports just $27m in worldwide sales for cholesterol-busting PCSK9 inhibitor Repatha, as reimbursement continues to present a big hurdle.
Dr Reddy's Laboratories is to market and distribute three Amgen therapies, including the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab) on the Indian market.