(Source: Pharmafile 2015-05-22）
The EMA has recommended eight medicines for approval in a round of reviews, including four new cancer indications.
Amgen’s Repatha (evolocumab), the first monoclonal antibody approved to treat high cholesterol, could be a new option for patients who are unable to control their cholesterol using statins. The drug is also indicated for homozygous familial hypercholesterolaemia, a rare inherited disorder in which levels of LDL-cholesterol are higher than normal from birth.
“Uncontrolled high cholesterol is a burden on the health system and we look forward to continuing to work with regulatory authorities to bring Repatha to patients across Europe,” says Amgen’s executive vice president of R&D Sean Harper.
Meanwhile, Bristol-Myers Squibb’s Opdivo (nivolumab) is likely to become the first EU-approved immunotherapy for squamous non-small cell lung cancer (NSCLC) following a nod from the regulator.
Opdivo was previously approved in Europe for advanced melanoma in April, beating its rival immunotherapy – Merck’s Keytruda (pembrolizumab) – to the post, despite Keytruda winning the race in the US.
However Merck’s drug has now finally caught up, receiving a recommendation for advanced melanoma in the latest round of approvals.
The EMA also recommended extending the use of Janssen and Pharmacyclics’ Imbruvica (ibrutinib) to include the treatment of patients with Waldenstrӧm’s macroglobulinaemia, a rare blood cell cancer – which could make Imbruvica the first treatment available for this disease in Europe.
The condition is characterised by an excess of abnormal white blood cells, called B lymphocytes and plasma cells, in the bone marrow and sometimes in other organs, which can lead to the blood becoming thicker than normal.
Imbruvica was first authorised in the European Union in October 2014 for the treatment of two other types of blood cancer: chronic lymphocytic leukaemia and mantle cell lymphoma.
Another first-in-class orphan drug, United Therapeutic’s monoclonal antibody Unituxin (dinutuximab), was recommended for treating high-risk neuroblastoma. This rare cancer forms from immature nerve cells and typically occurs in children under five years old.
And theres more
The Committee for Medicinal Products for Human Use (CHMP) also recommended Evotaz (atazanavir/cobicistat) for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.
Omidria (phenylephrine/ketorolac) received a position opinion for the maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.
Two generic medicines also received a positive opinions: Bortezomib Accord (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma, and Pregabalin Zentiva (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.
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