After Settlement with Lilly, Eagle Pharma Gets Pemfexy Go-Ahead from FDA

The U.S. Food and Drug Administration (FDA) approved Eagle Pharmaceuticals’ Pemfexy (pemetrexed for injection), what it is calling a branded alternative to Eli Lilly and Co.’s Alimta.

On December 13, 2019, Eagle and Eli Lilly reached a settlement, which allowed the FDA to shift the approval from tentative to final. The December announcement allowed for an initial limited entry of Pemfexy into the market on February 1, 2022, with an uncapped entry on April 1, 2022. The lawsuits were over patents.

The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.

Pemfexy is a ready-to-dilute formulation of pemetrexed indicated for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in combination with cisplatin; for locally advanced or metastatic nonsquamous NSCLC that hasn’t progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; for locally advanced or metastatic NSCLC after previous chemotherapy as a single agent; and for malignant pleural mesothelioma that can’t be treated surgically or for patients who are otherwise not eligible for surgery in combination with cisplatin.

“We are pleased to receive final approval from FDA and look forward to making Pemfexy available to the patients who can benefit,” said Scott Tarriff, Eagle’s chief executive officer. “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.”

The company, as it worked through the litigation with Lilly, has otherwise been busy. On January 13, 2020, it entered into a new exclusive worldwide license agreement with the University of Pennsylvania to develop dantrolene sodium for Alzheimer’s disease. Penn, with Eagle’s participation, presented proof-of-concept preclinical work in July 2019 showing that intranasal dosing of the drug had therapeutic effects on memory and cognition in a mouse model of Alzheimer’s.

The drug appears to restore intracellular calcium regulation, which is believed to be required for proper nervous system function.

“Our collaboration with University of Pennsylvania builds on Eagle’s strategy to develop and commercialize therapies for critical care and disorders that have significant unmet patient needs, such as Alzheimer’s disease, the most common form of dementia,” Tarriff stated at the time. “Dantrolene sodium’s potential for use in treating Alzheimer’s patients represents novel thinking backed by years of proprietary Eagle research. Preclinical work around this has proven positive thus far and builds on Eagle’s years of insight gained in multiple clinical and preclinical studies on dantrolene sodium.”

And only a few days before that, on January 9, Eagle announced it has resubmitted its New Drug Application (NDA) for Ryanodex (dantrolene sodium for injectable suspension) for exertional heat stroke (EHS) as well as body cooling. The company received a Complete Response Letter (CRL) in July 2017. The company believes it has addressed all the issues raised in the CRL.

EHS is one of the most severe types of heat-related illness. It is marked by core body temperate of 104 degrees F or greater, which includes significant neurological issues, such as sudden changes in behavior, seizures or coma. Ryandex is indicated for treatment of malignant hyperthermia with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.