Eagle Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its novel ready-to-dilute pemetrexed (Alimta) formulation.
The chemotherapy drug, which works by inhibiting the synthesis of nucleotides that make up DNA strands, impairing the cells from dividing and leading to their death, is currently used in the clinic in combination with Platinol (cisplatin) to treat patients with malignant pleural mesothelioma or with locally advanced or metastatic non-small cell lung cancer.
Eagle’s NDA is for a multidose formulation of pemetrexed that can be readily diluted and used for the same indications of the Alimta powder formulation marketed by Eli Lilly and Company.
“We look forward to the FDA’s decision on this NDA this year, and to continuing to work closely with the FDA through the review process,” Eagle CEO Scott Tarriff said in a news release. “We believe our [ready to dilute] liquid formulation will be well received, adding to Eagle’s growing commercial portfolio of improved formulations, benefiting patients and shareholders alike.”
Alimta was approved to treat malignant pleural mesothelioma patients, in combination with Platinol, in February 2004. The approval was based on data from a multicenter, randomized trial that showed superior effectiveness in patients treated with Alimta plus Platinol compared to patients receiving Platinol alone.
In particular, patients receiving Alimta in combination with Platinol demonstrated improved survival rates, compared to the group receiving Platinol alone (12.1 months vs. 9.3 months).
In the trial, Alimta (500 mg per square meter of body surface) was diluted in 100 ml saline solution and injected in patients in a 10-minute intravenous infusion, followed by Platinol administration for two hours.
If approved, the new pemetrexed product would be administered through IV infusion, similar to Lilly’s formulation, but the powder is already dissolved in the saline solution and only needs to be further diluted to reach the appropriate concentration.