EMA Recommends Ten Drugs for Approval
Two of the medicines recommended for approval are orphan drugs.
At the November 2017 meeting of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), 10 new medicines were recommended for approval. Among the approved drugs were two with orphan designation: Jorveza (budesonide), which treats eosinophilic esophagitis, and Prevymis (letermovir), an antiviral to prevent “cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic hematopoietic stem cell transplant.”
Other medicines that received marketing authorization approval included treatments for multiple sclerosis (Ocrevus), hemophilia A (Adynovi), eosinophilic asthma (Fasenra), and vulvar and vaginal atrophy (Intrarosa). Mvasi (bevacizumab), a biosimilar for the treatment of a variety of types of cancer, was also recommended for approval. Other generic drugs that were approved include HIV treatments Darunavir Krka (darunavir) and Darunavir Krka d.d. (darunavir) and breast cancer treatment Fulvestrant Mylan (fulvestrant).
CHMP also recommended extending the therapeutic indications for Adcetris, Genvoya, Nplate, and Orkambi. The committee’s review of Zinbryta (daclizumab), which treats multiple sclerosis, found that further restrictions were needed to reduce the risk of liver damage.
Source: EMA
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
