Six medicines, including two new combination therapies for chronic hepatitis C, are lining up for EU approval after having been recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Gilead’s Epclusa (sofosbuvir/velpatasvir) and MSD’s Zepatier (elbasvir/grazoprevir) both won backing as treatments for chronic hepatitis C infection; the former for all six genotypes of the virus and the latter for genotypes 1 and 4.
Both belong to the next-generation of hepatitis therapies called direct antivirals, which block the action of proteins essential for viral replication; Epclusa targets the proteins NS5B and NS5A, while Zepatier targets NS3/4A and NS5A.
The regulator noted that these new regimens allow cure of patients with chronic HCV infection without the need for interferons, which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of patients.
Elsewhere, AstraZeneca’s Qtern was put forward for clearance as a treatment for type 2 diabetes.
The therapy is a fixed-dose combination of the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin and the human sodium-glucose co-transporter 2 (SGLT2) dapagliflozin, thereby offering a dual approach to lowering blood glucose.
Three new generic medicines also won CHMP backing: Bortezomib Hospira (bortezomib) and Bortezomib Sun (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma; and Pemetrexed Fresenius Kabi (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.
On the downside, Takeda Pharma’s Ninlaro (ixazomib) was given a thumbs down for treating multiple myeloma in adults who had received at least one prior treatment.
The CHMP concluded that, based on the currently available data, the drug’s benefits did not outweigh its risks and recommended that it be refused marketing authorisation.
Takeda said it is disappointed with the decision. “We stand behind the TOURMALINE-MM1 trial data, which were recently published in the New England Journal of Medicine and demonstrated a significant extension in progression-free survival for Ninlaro + lenalidomide and dexamethasone vs. placebo + lenalidomide and dexamethasone and a favorable benefit-risk profile,” noted Christophe Bianchi, president of Takeda Oncology.
The drug was approved by the US Food and Drug Administration in November last year following a priority review.
