The latest set of opinions from the European Medicines Agency includes recommendations for AstraZeneca/Bristol-Myers Squibb's new diabetes drug, Novartis' rare blood cancer treatment and an iron drug from Takeda.
First up, the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of AZ/B-MS' Forxiga (dapagliflozin) for type 2 diabetes in combination with other glucose-lowering products including insulin and as a monotherapy in metformin- intolerant patients. Dapagliflozin is the first drug in the class of sodium-glucose co-transporter 2 (SGLT2) inhibitors and the positive opinion is based on data from 11 Phase III trials.
The European thumbs-up comes some three months after the US Food and Drug Administration issued a complete response letter for dapagliflozin, and requested additional data from ongoing studies amid concerns of possible liver damage and a potential link with breast and bladder cancer. However the EMA says the CHMP "assessed these concerns and found that they are satisfactorily addressed in the product information and in the risk management plan for Forxiga". The agency also noted that as the effects of dapagliflozin are dependent on kidney function, its use is not recommended in patients with moderate to severe kidney impairment.
Meantime, the EMA has also given a provisional green light to Novartis' Jakavi (ruxolitinib) as a treatment for myelofibrosis. If approved, it will be the first in a new class of drugs, JAK inhibitors, to get the green light in Europe and the first for MF, an uncommon, life-threatening blood cancer characterised by bone marrow failure and enlarged spleen (splenomegaly).
The drug, licensed from Incyte, was approved in the USA in November last year. In Europe, MF affects about 0.75 out of every 100,000 people annually.
The CHMP has also adopted a positive opinion on Takeda's Rienso (ferumoxytol) for the intravenous treatment of iron deficiency anaemia in adults with chronic kidney disease. The drug, which is licensed from AMAG Pharmaceuticals, is sold in the USA and Canada by Feraheme.
SkyePharma is another firm with cause to celebrate the latest round of opinions, after getting a recommendation at long last for the asthma drug Flutiform (fluticasone and formoterol). The combo will compete with GlaxoSmithKline’s Advair (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide and formoterol) and be marketed by partner Mundipharma.
SkyePharma chief executive Peter Grant said that "this is a strong endorsement of our capabilities in developing innovative and complex respiratory products". An excellent day for the firm had begun with the receipt of a $10 million milestone payment from Pacira Pharmaceuticals following the recent launch in the USA of Exparel (bupivacaine liposome injectable suspension) for postsurgical analgesia. The two pieces of news saw SkyePharma shares soar nearly 107% to close at 85.50 pence.
Other decisions of note at the EMA meeting included confirmed rejections of Amsterdam Molecular Therapeutics' gene therapy product Glybera (alipogene tiparvovec) for patients with lipoprotein lipase deficiency and Allos Therapeutics' Folotyn (pralatrexate) for peripheral T-cell lymphoma.