FDA News Roundup: Eisai, Pfizer, Roche, Boehringer Ingelheim, And More

CINV Drug Granted FDA Approval

Helsinn and Eisai announced that their drug Akynzeo, indicated for the prevention of chemo-induced nausea and vomiting, became the first approved fixed combination oral treatment to combine an NK1 receptor antagonist and palonosetron (5-HT3 receptor agonist) in one capsule. The drug was investigated in Phase 2 and Phase 3 trials in patients that needed moderately to highly emetogenic chemotherapy regimens to treat their cancer. In the trials, patients taking Akynzeo had fewer emetic episodes and did not need to use rescue medication compared to those taking palonosetron as a monotherapy.

Pfizer NDA Given Priority Review

Pfizer’s New Drug Application (NDA) for palbociclib in combination with letrozole for women with treatment-naïve estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer was accepted for priority review early last week. The company submitted the application following a Phase 2 trial, known as PALOMA-1, which compared palbociclib + letrozole against letrozole as a monotherapy in breast cancer patients. The company expects an FDA decision by April. The drug garnered attention from the FDA in the spring of 2013 when the agency designated the combination a Breakthrough Therapy for the first-line treatment of advanced or metastatic ER+, HER2- breast cancer. The drug halts the work of cyclin-dependent kinases 4 and 6, which are responsible for the spread of tumor cells.

FDA Grants Priority Review To Lenvatinib NDA

The NDA for lenvatinib mesylate, submitted by Eisai, was accepted for Priority Review by the FDA. The drug is indicated for the treatment of progressive radioiodine-refractory differentiated thyroid cancer.  The company is awaiting the decision of several regulatory agencies worldwide, including those in Europe, Japan, and the U.S. The drug has already garnered orphan drug designations for thyroid cancer in Japan, the EU, and in the U.S., and is currently up for accelerated review by the EMA. Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor that halts the kinase activities of VEGFR, FGFR, PDGFRalpha, KIT, and RET, which are implicated in the spread of tumors.

Rufinamide sNDA Accepted For Priority Review

Eisai’s supplemental NDA for Banzel (rufinamide) was granted priority review as an adjunctive treatment for patients ages 1 to 4 suffering from Lennox-Gastaut Syndrome (LGS)-induced seizures. Since 2008, the drug, a triazole derivative, has been available as an adjunctive treatment for patients 4 and up. While the clinical impact of the drug’s structure (different than other antiepileptic drugs) is unclear, researchers believe the drug’s structure enables it to regulate sodium channel activity in the brain that is often implicated in seizures.

Roche’s Esbriet Wins FDA Approval For IPF

Roche’s acquisition of idiopathic pulmonary fibrosis drug Esbriet from InterMune last month was a good move for the company, as the FDA awarded approval for the drug last week. This new drug will grant a much needed, new treatment option for patients with the lung-scarring disease that, until this point, has commonly been treated with oxygen therapy, pulmonary rehabilitation, and lung transplants. The approval came 5 weeks before the expected decision date, though approval had been a long time coming. Pirfenidone had previously received approval from European regulators, however the FDA rejected the drug in 2010 because its clinical benefit couldn’t be determined following two late-stage clinical trials. Now that it has been approved, the drug is expected to cost $94,000 a year in the U.S.—about $50,000 more than it costs per year in the EU and Canada.

Boehringer Ingelheim Ofev Garners Approval For IPF

The same day Roche received approval for Esbriet in IPF, Boehringer Ingelheim also won the FDA’s vote of approval for its IPF drug, Ofev. Nintedanib has been awarded a great amount of FDA attention in the past, being the recipient of fast track status, priority review, and orphan drug and breakthrough therapy designations. The kinase inhibitor was tested in 1,231 patients in three clinical trials, in which it demonstrated its ability to promote a decline in forced vital capacity compared to those taking placebo.  

FDA Rejects Pfizer’s Black Box Warning Proposal

Despite the release of new data showing that Pfizer’s quit-smoking drug Chantix does not cause aggression and mental health issues in patients, the FDA advisory panel has still voted to retain the drug’s black box warning. Following the release of the drug’s newest data, the FDA altered a portion of the drug’s label to say the pill does not cause suicidal thoughts and behavior. Pfizer then moved to have the black box warning stricken from its label all together.  While the advisory committee still plans to keep the black box warning on the label for now, it has said it will open the floor up for discussion again once Pfizer releases data from a post-marketing study being conducted in 8,000 people. This post-marketing study, expected to be completed in Q3’15, aims to determine if the drug does cause neuropsychological effects compared to placebo and two other stop-smoking drugs.

FDA Requests More Info From Insys

Insys was instructed to go back to work by the FDA last week when the agency turned away its application for Dronabinol oral solution, a synthetic version of tetrahydrocannabidiol, in the treatment of anorexia in AIDs patients and cancer patients with CINV.  The agency says that the application did not contain enough information on the company’s pediatric study plan. The company does not expect it will have to carry out further clinical studies in order to provide the FDA with the requested information.