Six medicines, including two orphan medicines, recommended for approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use(CHMP) recommended six new medicines for marketing authorisation at its February 2016 meeting.

The CHMP recommended granting marketing authorisations for two medicines for the prevention and treatment of bleeding in patients with haemophilia B, Alprolix(eftrenonacog alfa) and Idelvion (albutrepenonacog alfa). Both these medicines have an orphan designation.

Lonsurf (trifluridine / tipiracil) was recommended by the CHMP for the treatment of metastatic colorectal cancer.

Descovy (emtricitabine / tenofovir alafenamide) received a positive opinion for the treatment of HIV infection.

The CHMP recommended granting a marketing authorisation for Taltz (ixekizumab) for the treatment of plaque psoriasis.

The generic medicine Palonosetron Hospira (palonosetron) received a positive recommendation from the Committee for the prevention of nausea and vomiting associated with chemotherapy.

Seven recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Giotrif, Humira,Ruconest, TachoSil, Zydelig and two extensions of indications for Opdivo. For more information on the extensions of indications for Opdivo, please see the press release in the grid below.

Start of review: medicines containing dienogest and ethinylestradiol

The CHMP started a review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg when used for acne. These products are available in several countries in the European Union (EU) as oral contraceptives and for the treatment of moderate acne in women. For more information, please refer to the start of referral document in the grid below.

Outcome of review on SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

The CHMP confirmed recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines). For more information, please see the public health communication in the grid below.

CHMP confirms recommendations to minimise risk of the brain infection PML with Tysabri

EMA’s scientific review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) is now completed, with the CHMP confirming the PRAC recommendations aimed at minimising this risk. For more information, please see the public health communication in the grid below.

PRIME and early access tools

The CHMP adopted the final document on PRIME, a new scheme to support the development of medicines addressing unmet medical needs, as well as revisedguidelines on the implementation of accelerated assessment and conditionalmarketing authorisation. These documents will be published on the EMA website in early March.

Posted on the EMA website on 26 February 2016