The European Medicines Agency recommended the approval of seven new therapies this month, including Novo Nordisk A/S's type 2 diabetes treatment Ozempic.
The agency's Committee for Medicinal Products for Human Use also recommended granting a marketing authorization for TiGenix NV's Alofisel to treat complex perianal fistulas, or tunnels caused by ulcers around the anus, in patients with Crohn's disease — an inflammatory bowel disease that affects the lining of the digestive tract.
The panel also recommended granting conditional marketing authorization to Kyowa Hakko Kirin Co. Ltd.'s Crysvita for the treatment of X-linked hypophosphatemia with radiographic evidence of bone disease in children and adolescents with growing skeletons, according to a Dec. 15 statement on its website.
X-linked hypophosphatemia is a rare, inherited disease characterized by abnormal loss of phosphate, which can lead to diminished height and deformity in the lower part of the body. Crysvita's conditional authorization would require it to fulfill specific obligations related to the completion of ongoing studies in children.
Diurnal Ltd's Alkindi, used to treat primary adrenal insufficiency — a rare hormonal disorder in infants, children and adolescents — was recommended to be given a pediatric-use marketing authorization. This approval helps extend the duration of drug's patent protection.
Two generic drugs were also recommended for approval including Mylan NV's anagrelide mylan, a copy of Shire plc's Xagrid, to reduce elevated platelet counts in patients at risk of essential thrombocythemia, a disorder under which excessive platelets are produced in the bone marrow.
Slovenian company Krka d.d.'s HIV treatment Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, a copycat version of Gilead Sciences Inc. and Bristol-Myers Squibb Co.'s Atripla, was the second generic medicine recommended for approval in December.
The EMA committee also backed South Korea-based Celltrion Healthcare Co., Ltd.'s Herzuma, a biosimilar version of Roche Holding AG's blockbuster cancer drug Herceptin, for treating breast and gastric cancer.
The panel issued a negative recommendation for Spanish drugmaker Pharma Mar SA's Aplidin, a potential treatment for multiple myeloma.
The London-based agency makes recommendations to the European Commission, which ultimately decides whether to approve or reject manufacturers' applications for marketing approval in the European Union.
