Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)’s lung cancer drug brigatinib has been accepted for review by the FDA. Additionally, the FDA has put the drug on its priority review list at the request of Ariad. Priority review means that it will take a shorter period to complete reviewing the drug for commercial approval.
As such, the FDA now has a goal to complete the review of brigatinib in six months as opposed to the typical 10 months or more. The FDA verdict on brigatinib is expected on April 29, 2017.
Ariad’s brigatinib is an ALK-inhibitor administered orally. The drug targets ALK+ (positive) lung cancer non-small cell lung cancer (ALK+ NSCLC) patients who have failed treatment with crizotinib.
In seeking regulatory clearance to market brigatinib in the U.S., Ariad included data from Phase 1/2 as well as Phase 2 ALTA trials of the candidate. Ariad is confident that the FDA will clear the drug. It is worth pointing out that brigatinib is already in FDA’s good books. The candidate was granted Breakthrough Therapy designation by the FDA for treatment of ALK+ NSCLC patients who are not responding favorably to crizotinib medication.
Additionally, brigatinib carries FDA’s Orphan Drug Designation for a treatment of several subsets of lung cancer patients, include those who are EGFR-positive, ROS1-positive and ALK-positive.
Seeking European approval
After submitting to the FDA, Ariad has set its eyes on appealing to the European regulators to also approve the drug. The company plans to submit application for brigatinib to the European Medicines Agency (EMA) early next year.
Commenting on the FDA application for brigatinib, Ariad’s CEO Paris Panayiotopoulos said they were excited that their significant R&D investment in brigatinib was about to bear fruit. Panayiotopoulos promised that they will continue to work with regulators to bring treatment solutions to underserved patient populations, especially those with rare diseases.
Ariad was scheduled to release its 3Q16 results on November 1, the same date as its rival Gilead Sciences Inc. (GILD). For 2Q16, Ariad generated revenue of $68 million, more than double $29.24 million in the same period a year earlier. Gilead on the other hand reported revenue of $7.50 billion, down 9.6% YoY.