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EU agency recommends 84 new medicines in 2018, reviews heart drugs with impurity


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EU agency recommends 84 new medicines in 2018, reviews heart drugs with impurity

The European Medicines Agency recommended 84 new medicines for marketing authorization in 2018 and initiated a review of hypertension drugs after finding traces of a potential cancer-causing compound.

During 2018, Novartis AG's Kymriah and Gilead Sciences Inc.'s Yescarta became the first two CAR-T cell therapies to receive the CHMP's positive opinion for treating different types of blood cancers in EU.

Kymriah is intended for acute lymphoblastic leukemia and diffuse large B-cell lymphoma, while Yescarta will be used for diffuse large cell lymphoma and primary mediastinal B-cell lymphoma.

Aimovig, another Novartis drug, won the committee's backing to be the first human monoclonal antibody intended to prevent migraines. The drug belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

The year also marked the first positive opinion granted to a vaccine against dengue fever. If approved, Sanofi's Dengvaxia will be used to prevent dengue fever caused by dengue virus serotypes 1, 2, 3 and 4 in the EU. The vaccine is for people aged between 9 and 45 who live in an endemic area and already had a previous case of dengue virus infection.

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CHMP also adopted a positive opinion for Sanofi's Fexinidazole Winthrop, the first all-oral treatment to address both stages of sleeping sickness, a potentially fatal disease endemic to Africa.

Meanwhile, with 15 biosimilars recommended for approval in 2018, the EMA maintained its highest record of biosimilars to receive the agency's backing since 2006.

Biosimilars are biological products that act in the same way as their existing regulatory-approved reference products. Biosimilars are intended to be lower-cost versions of biologic therapies.

The committee recommended five biosimilar versions of Amgen Inc.'s bone marrow stimulant Neulasta — Accord Healthcare Ltd.'s Pelgraz, ERA Consulting GmbH with Udenyca, Fulphila by Mylan NV, Cinfa Biotech S.L's Pelmeg and Novartis with Ziextenzo — making it the top biologic therapy with most biosimilars waiting for the European Commission's marketing nod.

AbbVie Inc.'s blockbuster drug Humira is also set to face new biosimilar competition as four more were backed for approval by CHMP. Novartis' Halimatoz, Hefiya and Hyrimoz were granted positive opinion in May, followed by Mylan's Hulio in July.

Three biosimilars for Roche Holding AG's cancer drug Herceptin also made the cut in 2018 — Allergan PLC's Kanjinti, Pfizer Inc.'s Trazimera and Mylan's Ogivri. Like Herceptin, these three medicines are intended to treat breast and gastric cancer.

Valsartan review

In July, the EU regulator disclosed an ongoing review of certain medicines containing the active ingredient valsartan manufactured and supplied by Chinese company Zhejiang Huahai Pharmaceutical Co. Ltd.

Medicines containing valsartan, which was developed by Novartis and marketed under the Diovan brand, are used to treat high blood pressure and heart failure.

According to EMA, traces of the impurities N-nitrosodimethylamine and N-nitrosodiethylamine — NDMA and NDEA, respectively — were found in Zhejiang Huahai's products. Both NDMA and NDEA could potentially cause cancer in humans.

Following news of the review, several companies like Teva Pharmaceutical Industries Ltd., Mylan, Major Pharmaceuticals Inc., and Solco Healthcare voluntarily recalled their certain high blood pressure and heart medicines containing valsartan.

The review was extended in September to include other "sartan" medicines such as candesartan, irbesartan, losartan and olmesartan. Low levels of NDEA were discovered in irbesartan products manufactured by India's Aurobindo Pharma Ltd.

The ongoing review is being conducted by CHMP and its opinion will be forwarded to the EC, which will then issue a final legally binding decision on the matter, applicable in all EU member states.

Brexit update

In a Dec. 14 report from the EMA management board, the agency said its 2019 budget will decrease by 1.4% year over year to about €333 million as it relocates its headquarters to Amsterdam from London following the U.K.'s decision to exit the EU.

EMA noted that its temporary office in Amsterdam will be fully operational beginning Jan. 1, 2019.

According to the agency, its budget is expected to stabilize in 2020 after the resumption of all its activities. Some of its activities were scaled back to cope with 30% Brexit-related staff loss, higher than what was previously projected.

Meanwhile, based on a survey among drugmakers, the EU health regulator narrowed down the number of drugs at risk of a post-Brexit supply disruption in the U.K. from 39 to its estimate of 109 in July.