What You Missed From Regulatory Agencies Last Week—July 28-August 1, 2014

Novo Nordisk’s Xultophy Receives EMA Positive Opinion

Xultophy received a positive opinion from the CHMP and EMA recommending marketing authorization for the treatment of adults with type 2 diabetes mellitus. The drug aims to improve glycemic control in combination with oral-glucose lowering products when these alone or combined with basal insulin do not succeed in controlling glucose levels. The treatment was previously known as IDegLira and is a combination of Tresiba and Victoza (liraglutide)—two of Novo Nordisk’s biggest assets in its diabetes pipeline.

Alcon’s Simbrinza Earns EU Approval

Alcon, the eye-care division of Novartis, announced that its Simbrinza eye drops suspension received approval from the EC for glaucoma. The drug has been approved to decrease intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension when monotherapy is insufficient. A combination treatment comprising brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL, Simbrinza is administered via drops to the eye twice daily. The drug does not contain a beta-blocker, which is generally found in drugs indicated for lowering IOP.

Norway Grants Marketing Authorization To pSivida’s Iluvien

Iluvien, for the treatment of vision impairment due to chronic diabetic macular edema (DME), received marketing authorization in Norway last week. There are still nine countries in which marketing authorization is pending for the treatment. The drug was also just approved for reimbursement in Portugal by INFARMED—the marketing authorization body of the Portuguese Ministry of Health. pSivida is currently awaiting a decision from the U.S. FDA and has a late September Prescription Drug User Fee Act (PDUFA) goal date. Approval by the FDA would grant the company a $25M milestone payment from Alimera.

Takeda Receives Positive CHMP Opinions For T2 Diabetes Drugs

Takeda announced that it has received CHMP positive opinions for label updates to several alogliptin drugs. The CHMP has approved an update to the Summary of Product Characteristics for Vipidia (alogliptin), and for the fixed-dose combination therapies Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone). Should the EC adopt these recommendations, cardiovascular safety outcomes data would be a necessary part of all alogliptin labeling. These updates came from the findings of two clinical studies, EXAMINE and ENDURE.

Vertex’s  Kalydeco Receives European Approval

The EC has approved Kalydeco for patients age 6 and up suffering from cystic fibrosis (CF) that have 8 additional gating mutations in the CF transmembrane conductance regulator (CFTR) gene. In June, the treatment received a positive opinion from the CHMP. Kalydeco was previously approved in Europe in July 2012 for patients with G551D mutation. This latest approval is based on the results from the first part of a phase 3 study of 39 people with CF who have a non-G551D gating mutation.

Intravenous Formulation of Noxafil Receives CHMP Thumbs Up

A new formulation of Merck’s Noxafil (posaconazole) for the treatment of invasive Aspergillus and Candida infections received a positive opinion from the CHMP. Should the EC adopt the CHMP’s opinion, the drug in its investigative intravenous formulation, will be granted centralized marketing authorization with unified labeling valid in 28 countries in the EU, as well as Iceland, Liechtenstein, and Norway. The drug has already received marketing authorization in tablet and oral suspension form.

Soliris Named Orphan Drug In EU

Alexion Pharma’s Soliris (eculizumab) for rare neurological disease Myasthenia Gravis (MG) was designated an orphan drug by the EC. The drug is a first-in-class terminal complement inhibitor and is currently approved for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical emolytic uremic syndrome (aHUS). Soliris is not currently approved anywhere for the treatment of MG. Alexion is enrolling patients in a multinational, placebo-controlled registration trial of eculizumab in patients with refractory generalized MG.