EMA Recommends Nine Drugs for Approval

Regulatory NewsRegulatory News | 11 November 2016 |  By 

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (insulin aspart) for diabetes, Sanofi’s Suliqua (insulin glargine/lixisenatide) for the treatment of Type 2 diabetes and Gilead’s Vemlidy (tenofovir alafenamide) for chronic hepatitis B.

Three of the four new treatments have already been approved by the US Food and Drug Administration (FDA), including FDA's approval of Vemlidy on Thursday. The US regulator has until later this month to decide on Sanofi’s treatment, after requesting more information on the delivery device.

On the biosimilars front, three new ones were recommended for approval by CHMP: Merck Sharp & Dohme’s Lusduna (insulin glargine) for the treatment of diabetes, as well as STADA Arzneimittel’s Movymia and Gedeon Richter’s Terrosa (both contain teriparatide) for the treatment of osteoporosis.

None of those treatments have been approved by US FDA, though Merck in August submitted a new drug application for its insulin glargine biosimilar in the US, with partial funding from Samsung Bioepis.

CHMP also recommended two generic medicines for approval: Mylan’s darunavir for the treatment of HIV-1 infection and Mylan’s tadalafil for the treatment of pulmonary arterial hypertension. US FDA first authorized Mylan’s darunavir generics in 2013, though for tadalafil, better known as Cialis in the US, there are no generics on the market yet.

In addition, EMA recommended extensions of indications for Novartis’ Arzerra (ofatumumab), Genzyme’s Caprelsa (vandetanib), AbbVie’s Humira (adalimumab), Pfizer’s Nimenrix (meningococcal group A, C, W135 and Y conjugate vaccine) and UCB Pharma’s Vimpat (lacosamide).

CHMP also completed a scientific assessment of the annual renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy (DMD)treatment Translarna (ataluren), recommending that the conditional marketing authorization be renewed. In the US, FDA last February sent a refuse-to-file decision to PTC after the agency said the company’s application for the treatment was not sufficiently complete.

As part of the CHMP assessment for Translarna, the regulator requested that PTC conduct a new 18-month randomized, placebo-controlled study in DMD patients, followed by an 18-month period where all patients will be switched to Translarna. The study results are expected to be available in the first quarter of 2021.

Overall in 2016, CHMP has now issued positive opinions on 73 medicines, including new treatments, biosimilars and generics, and 50 positive opinions on extensions of therapeutic indications.


© 2023 Regulatory Affairs Professionals Society.

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