- A committee from the European Medicine's Agency has recommended nearly a dozen drugs for approval, including a biosimilar diabetes medication from Sanofi and a plaque psoriasis treatment that AstraZeneca licensed to LEO Pharma.
- Fellow big pharma Novartis also received good news, as its metastatic non-small cell lung cancer (NSCLC) drug Zykadia (ceritinib) got the Committee for Medicinal Products for Human Use (CHMP)'s green light for a label expansion covering first-line treatment of patients with the anaplastic lymphoma kinase (ALK)-positive form of the disease.
- With positive opinions from the CHMP in hand, those medications now head to the European Commission for final market authorization.
The most important wins coming out of the CHMP's May meeting were with Zykadia and brodalumab — which AstraZeneca out-licensed to Leo Pharma in Europe, Kyowa Hakko Kirin Co. in Japan and several other Asian countries, and Valeant in the U.S.
For Novartis, Zykadia entering European markets as a first-line treatment for NSCLC patients with ALK-positive tumors would be a helpful precedent for approval across the pond.
The Food and Drug Administration already granted the drug accelerated approval to treat ALK-positive patients who didn't respond to Pfizer's Xalkori (crizotinib), and recently accepted a supplemental New Drug Application (sNDA) for Zykadia as a first-line therapy. What's more, the agency granted it both breakthrough designation and priority review, meaning the treatment should get a thumbs up or down for the expanded label sometime in the next few months.
As the NSCLC space continues to grow thick with competition, drugmakers have to looked to label extensions as a means of differentiation and competitive advantage. Therefore, an FDA OK for Zykadia as a first-line medicine for ALK-positive patients would be big for Novartis, allowing it to directly compete with Xalkori and stay ahead of second-line treatments, such as Roche's Alecensa (alectinib) and Takeda's Alunbrig (brigatinib).
Zykadia could use a boost too. The drug brought in just $91 million in 2016, after a tough fourth quarter. According to Novartis' year-end financial report, competition in the U.S. hurt sales.
Meanwhile, the recommendation for brodalumab bolsters LEO Pharma's dermatology offerings. In February, Valeant secured approval for the drug in the U.S., branding it as Siliq. But a black box warning for increased risk of suicidal ideation or behavior stands to hamper revenues.
Other new drugs receiving the go-ahead from the CHMP included Sanofi's biosimilar version of insulin lispro, Gedeon Richter's antipsychotic Reagila (cariprazine), Zentiva's generic efavirenz/emtricitabine/tenofovir disoproxil, and three biosimilar versions of rituximab from Celltrion Healthcare: Blitzima, Tuxella and Ritemvia.
In addition to Zykadia, the committee also recommended five more drugs receive label expansions. Three medicines — Adlumiz (anamoreline HCl), Masipro (masintinib) and XBiotech's human IgG1 monoclonal antibody specific to interleukin-1 alpha — were rejected.