Ten new medicines leap towards EU approval

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The European Medicines Agency’s Committee for Medicinal Products for Human Use has put 10 medicines forward for approval in the region, including new options for multiple sclerosis, eosinophilic esophagitis and eosinophilic asthma.
First up, the Committee has out forward Roche’s Ocrevus (ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).
The positive opinion provides an additional treatment option for patients with RMS and is the first medicine in the EU intended to treat some patients with PPMS. There are currently no disease-modifying therapies available for this particular form of MS so there is a great medical need for treatment of such a relentless, seriously debilitating disease.
Treatment with the drug significantly cut the annualised relapse rate by 46.4 percent at 96 weeks compared with interferon beta-1a treatment in patients with RMS. For patients with PPMS, treatment with Ocrevus led to a 24 percent reduction in the risk of 12-week confirmed disability progression compared with placebo.
The CHMP’s recommendation “is great news for people in Europe with active relapsing forms of MS as well as those with early primary progressive MS, who are all now one step closer to having this important new treatment option,’’ said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“We are pleased that the CHMP has recognised the clinical significance of the Ocrevus data, particularly for people living with primary progressive MS, a highly disabling disease that currently has no approved treatments in Europe.’’
The drug was approved in the US back March.
Elsewhere, MSD’s orphan drug Prevymis (letermovir), an antiviral that prevents cytomegalovirus (CMV) reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant, has also been recommended. The drug has just been approved in the US.
“For far too long we’ve been trying to juggle the toxicities of older drugs. Letermovir offers an opportunity to reduce the CMV-related treatment burden, with a clear reduction in viral reactivation,” said Prof. Karl Peggs, Honorary Consultant in Haematology/Transplantation at UCL Hospitals. “This is great news both for the treating physicians and the patients we treat.”
Dr. Falk Pharma’s Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. There is currently no approved medicine available for the condition and the drug reviewed under the accelerated assessment procedure, which is reserved for medicines of major public health interest.
Also winning CHMP favour this month were: Shire’s Adynovi (rurioctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A; AstraZeneca’s Fasenra (benralizumab) for the treatment of severe eosinophilic asthma; Endoceutics’ Intrarosa (prasterone), for the treatment of vulvar and vaginal atrophy in postmenopausal women; and Amgen’s Avastin biosimilar Mvasi (bevacizumab), for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
Three generic medicines were also backed for approval: Darunavir Krka (darunavir) and Darunavir Krka d.d. (darunavir), both for the treatment of HIV-1 infection; and Fulvestrant Mylan (fulvestrant), for the treatment of locally advanced or metastatic breast cancer.
Continue at: http://www.pharmatimes.com/news/ten_new_medicines_leap_towards_eu_approval_1211217
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