FDA approves Eagle's Pemfexy

Patients with certain types of non-small cell lung cancer have a new branded drug injection alternative to Alimta. The Food and Drug Administration has greenlighted Eagle’s Pemfexy (pemetrexed for injection).

“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,” said Eagle CEO Scott Tarriff.

The conversion from tentative to a final approval follows the company’s settlement agreement reached with Eli Lilly on Dec. 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 Allimta utilization) on Feb. 1, 2022, and a subsequent uncapped entry on April 1, 2022.

The company received tentative approval for Pemfexy in 2017, reflecting FDA’s conclusion that the product met all required quality, safety and efficacy standards, but at the time was not eligible for marketing in the United States because of existing patent protections.