Three Strikes But Not Out: GSK Maneuvers Through A Third R&D Setback
This article was originally published in Pharmaceutical Approvals Monthly
GlaxoSmithKline’s decision to end a Phase III trial testing the cancer immunotherapy MAGE-A3 in NSCLC is no surprise, following disappointing results in two trials, but coupled with other disappointing R&D news it puts more pressure on the company to deliver on its respiratory launches.
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Targeting inflammation appears to be a promising complementary approach to lipid-lowering drugs in atherosclerosis, but the question of which pathway in a complex system to target remains open. The failure of GlaxoSmithKline’s darapladib in the STABILITY trial may have dealt a fatal blow to phospholipase A2 enzymes as targets, but the interleukin-6 pathway is gaining attention with the ongoing CANTOS study of Novartis’ canakinumab and the NHLBI’s CIRT study of low-dose methotrexate.
FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.
GlaxoSmithKline is counting on new products like Breo Ellipta and Anoro Ellipta to extend its legacy in respiratory disease beyond Advair Diskus, which could face generic competition within the next five years. But GSK may need to wage a battle on the reimbursement front before it can claim commercial success – a challenge highlighted by Express Scripts’ unexpected decision to put Advair and Breo on its not covered list for 2014.