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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016

• Six medicines, including one new antibacterial recommended for authorisation in the EU; antiseptic gel for newborns receives positive scientific opinion for use outside the EU

London, UK (April 29, 2016) – At its April meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Umbipro (chlorhexidine digluconate), an antiseptic gel to prevent umbilical cord infections (omphalitis) in newborn babies, for use in countries outside the European Union (EU).

Umbipro was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows the Agency to assess the quality, safety and efficacy of a medicine and give an opinion on its benefit-risk balance when used in low-income countries outside the EU. For more information on Umbipro and the Article 58 procedure, please see the press release and infographic in the grid below.

In addition, six medicines were recommended for marketing authorisation in the EU. These recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation:

Zavicefta (ceftazidime / avibactam), a new treatment option against multi-drug resistant bacteria was recommended for approval by the Committee. The medicine is to be used in adult patients with intra-abdominal infection, urinary tract infection, as well as pneumonia acquired in a hospital setting. It is also indicated for the treatment of adults with infections caused by certain Gram-negative bacteria, for which there are only limited treatment options. For more information on Zavicefta, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Zinbryta (daclizumab)for the treatment of relapsing forms of multiple sclerosis.

Ongentys (opicapone) received a positive opinion from the Committee for the treatment of Parkinson’s disease and motor fluctuations.

The CHMP gave a positive opinion for Odefsey (emtricitabine / rilpivirine / tenofovir alafenamide) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Enzepi (pancreas powder) received a positive opinion for the treatment of exocrine pancreatic insufficiency.

EndolucinBeta (lutetium (177 lu) chloride) also received a positive opinion. It is a radiopharmaceutical precursor that has to be combined with another medicine, a carrier medicine, in a process called radiolabelling before administration. The carrier medicine then takes EndolucinBeta to the disease site in the body where it gives off beta-radiation, allowing a localised radiation effect.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Sialanar (glycopyrronium bromide). Sialanar was intended for the treatment of persistent drooling in children and adolescents with neurological conditions. For more information, please see the questions-and-answers document in the grid below.

Nine recommendations on extensions of therapeutic indications

The Committee recommended adding treatment of follicular lymphoma to the approved indication for Gazyvaro. For more information on Gazyvaro, please see the press release in the grid below.

The CHMP also recommended extensions of indications for Afinitor, Avastin, Ferriprox, HyQvia, Imbruvica, Reyataz, Victoza and Zinforo.

Start of review on the conduct of studies at Semler Research Centre Private Ltd

The CHMP has started a review of medicines for which studies have been conducted at Semler Research Centre Private Ltd in Bangalore, India. This follows inspections by the FDA and the World Health Organization which raised serious concerns over data generated at Semler’s sites. For more information, please see the start of referral documents in the grid below.

Outcome of review of inhaled corticosteroids for chronic obstructive pulmonary disease

The Committee completed its review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD). The review confirmed the known risk of pneumonia with these products, but did not find conclusive evidence of differences in this risk between different products in this class. For more information, please see the public health communication in the grid below.

Agenda and minutes

The agenda of the April 2016 meeting is published on EMA’s website. Minutes of the March 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the April 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s April 2016 meeting, is available in the grid below.

Positive recommendations on new medicines

Negative recommendation on new medicine

Positive recommendations on extensions of therapeutic indications

Start of procedure

Public health recommendation

Outcome of harmonisation procedure

Other updates

European Medicines Agency (EMA), 29.04.2016 (tB).