Eisai, Pfizer, and Novartis meds get FDA love over the long weekend
- The FDA on Friday made a series of moves that will ensure that some major players in the pharmaceutical space feel plenty of love right before Valentine's Day.
- First, the agency approved Eisai's Lenvima (lenvatinib) for treatment of patients with "progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy."
- The FDA also accepted Pfizer's New Drug Application (NDA) for abuse-deterrent extended-release opioid candidate ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) for severe and chronic long-term pain management and granted a priority review for Novartis' exciting, and possibly game-changing, heart failure candidate LCZ696.
Who said Friday the 13th has to be unlucky—especially when it's right before Valentine's Day?
Lenvima, a kinase inhibitor, is an important option for thyroid cancer patients since there is a significant unmet need for those who are treatment refractory, the FDA explained in a press release. Meanwhile, Pfizer's NDA acceptance is significant in an era of sky-high opioid abuse in America. Acceptance was based on a pair of phase III trials for patients with chronic and severe non-cancer pain, and if ALO-02 eventually wins approval, it will be Pfizer's second abuse-deterring opioid (in this case an oxycodone formulation).
Finally, LCZ696's priority review, while expected, is undoubtedly letting Novartis breathe a sigh of relief. This heart failure candidate, which has produced truly promising results in a therapeutic area where effective meds are nearly impossible to come by, could become one of the most important drug launches (from an outcomes perspective) of the 21st century. There's been some research suggesting that LCZ696 might come with added dementia risk, but that's unlikely to deter approval.