Ariad Pharmaceuticals, Inc. (ARIA) recently declared the submission of a Marketing Authorization Application (MAA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the European Medicines Agency (EMA). ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been formerly treated with crizotinib. The U.S. Food and Drug Administration (FDA) is presently reviewing a New Drug Application for brigatinib filed by ARIAD and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).
“ARIAD’s submission of the brigatinib MAA to the EMA is one of many recent milestones highlighting our strong investment in internally discovered rare cancer therapies,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “Since announcing our definitive agreement to combine with Takeda, we remain focused on our accountability to our patients by propelling brigatinib forward and by preparing for its anticipated U.S. launch.”
“The brigatinib clinical trials have offered patients with refractory ALK+ NSCLC, counting those patients who have metastatic brain lesions, with a potential important treatment option,” said Maurice Perol, MD, Léon Bérard Cancer Center, Lyon, France. “Based on the clinical data we’ve seen to date, we are really excited by the prospect that appropriate patients in the EU may have access to brigatinib as a new targeted treatment.”
Allergan plc Ordinary Shares (AGN) recently declared that David Nicholson, Allergan’s Chief R&D Officer will deliver a presentation at the Leerink Partners 6th Annual Global Healthcare Conference on Wednesday, February 15th, 2016 at 1:30 p.m. ET in New York, New York.
The presentation will be webcast live and can be accessed on Allergan’s Shareholder Relations web site at http://ir.allergan.com. The webcast can also be accessed through the following URL: http://wsw.com/webcast/leerink28/agn.
An archived version will be available about two hours after the live presentation ends and can be accessed at the same locations for 180 days.