The US Food and Drug Administration and the European Medicines Agency have both reported high levels of new drug approvals in 2014.
The US FDA approved a total of 41 new Molecular Entities (NMEs) and Biologic License Applications (BLAs) last year, 14 more than it did in 2013. This is also the second-highest total after the record 53 approvals announced by the agency during 1996.
The final approval of last year was for Bristol-Myers Squibb’s Opdivo (nivolumab), for the treatment of unresectable or metastatic melanoma who no longer respond to other drugs, announced on December 22, while the year’s first approval, on January 8, was also for a Bristol-Myers Squibb product – Farxiga (dapaglifozin), used to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
Alogether, the FDA approved nine treatments for cancer in 2014, the others being: AstraZeneca’s Lynparza (olaparib) for advanced ovarian cancer; Amgen’s Blincyto (blinatumomab), to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL); Merck & Co’s Keytruda (pembrolizumab), for patients with advanced or unresectable melanoma who are no longer responding to other drugs; Gilead Sciences’ Zydelig (idelalisib) used in three types of blood cancers; Spectrum Pharmaceuticals’ Beleodaq (belinostat) for the treatment of peripheral T-cell lymphoma (PTCL); Novartis’ Zykadia (certinib) for late-stage lung cancer; Janssen Biotech’s Sylvant (siltuximab) for multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma; and Eli Lilly’s Cyramza (ramucirumab) for stomach cancer.
Another cancer-related approval was for Eisai’s Akynzeo (netupitant and palonosetron), to treat nausea and vomiting in patients undergoing cancer chemotherapy.
Meantime, the EMA reports that it recommended 82 new products last year – a total which includes generics – compared to 79 in 2013 and 57 the year before. Last year, EMA received 118 applications for initial marketing authorisations (MAs) and for 2015 it says it expects a similar number, at 114. More than 20% of these applications are forecast to be for treatments for rare diseases – these numbered 23 in 2014 and are expected to total 24 during the current year.
The Agency also says it is expecting a general increase in pre-authorisation activities in human-use medicines this year. In particular, it is forecasting a sustained increase in requests for scientific advice on clinical development, including parallel advice with health technology assessment (HTA) bodies, with the aim of facilitating timely access to medicines for patients.