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GSK's diabetes drug among CHMP recommendations

EMA committee also backs drugs from Bayer, Takeda and Linepharma France
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GlaxoSmithKline's (GSK) new diabetes drug Eperzan was among four new pharma products recommended for approval at the end of last week by the European Medicines Agency (EMA).

In its latest round of opinions, the Committee for Medicinal Products for Human Use (CHMP), which provides guidance on drugs for the EMA, also backed Bayer's hypertension treatment Adempas, Takeda's antipsychotic Latuda and Linepharma France's Hemoprostol for haemorrhage in women.

Eperzan (albiglutide) stood out among the recommendations as it is GSK's entrance into the market for GLP-1 agonists – an area of diabetes treatment currently dominated by Novo Nordisk's Victoza (liraglutide).

The CHMP recommendation covers the use of Eperzan to manage glycaemic control in people with type 2 diabetes as a monotherapy if metformin is inappropriate for the patient or as an add-on in combination with other diabetes treatments. It comes as a pre-filled pen injection and is taken once a week.

The drug marks GSK's return to the massive diabetes market following severe restrictions in the US and suspension in the EU for its previous type 2 diabetes product Avandia (rosiglitazone) after it was linked to an increase in cardiovascular risk. The FDA restrictions were later lifted after further analyses.

Forecasts for Eperzan are modest, however, as studies have shown it is not as effective as once-daily Victoza, while the US Food and Drug Administration (FDA) has announced it has delayed the expected review date of the drug by three months.

Bayer's Adempas recommended

The CHMP also gave a positive opinion to Bayer's Adempas (riociguat) for use in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH).

The drug is the first of a novel class of treatments called soluble guanylate cyclase (sGC)-stimulators to receive EU recommendation.

The positive decision was based on two clinical trial programmes, CHEST and PATENT, which assessed the efficacy of the drug via a change in the patient's exercise capacity as measured by a six minute walk test.

These results also supported the FDA approval of Adempas in October last year.

With recommendations in both the US and EU the drug is now well on course to live up to its potential as one of several potential blockbusters highlighted by Bayer in 2013.

Takeda's antipsychotic and Linepharma's Hemoprostol

Elsewhere in the CHMP opinions, Takeda received a recommendation for the use of Latuda (lurasidone) in the treatment of adults with schizophrenia.

The once-daily drug has shown it is able to improve psychotic symptoms in both short- and long-term studies, while also demonstrating low rates of weight increase and glucose disturbance – two side effects associated with antipsychotic medicines.

The final new drug recommended by the CHMP was Linepharma's Hemoprostol (misoprostol), which was backed to treat women who haemorrhage after giving birth due to a failure of the uterine muscles to contract normally.

The recommendation covers the drug's use when intravenous oxytocin is not available. Hemoprostol is intended exclusively for markets outside the EU.

Article by
Thomas Meek

27th January 2014

From: Sales, Regulatory

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