Eagle gets FDA final nod for branded alternative to Alimta

Eagle Pharmaceuticals (Nasdaq: EGRX) has received final approval from the US Food and Drug Administration for its novel product, Pemfexy (pemetrexed for injection), a branded alternative to Alimta, which generated global sales of $2.13 billion in 2019, for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC).

The conversion from tentative to a final approval follows the company’s settlement agreement reached with the drug’s originator, Eli Lilly (NYSE: LLY) on December 13, 2019. This agreement provides for a release of all claims by the parties and allows for an initial entry of Pemfexy into the market (equivalent to approximately a three-week supply of current Alimta utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

“We are pleased to receive final approval from FDA and look forward to making Pemfexy available to the patients who can benefit. Our initial market exclusivity for Pemfexy represents a significant opportunity for Eagle and builds on the successes of our expanding presence in the oncology space,” stated Scott Tarriff, Eagle’s chief executive.