Merck wins double approval in Europe
pharmafile | September 3, 2010 | News story | Sales and Marketing | Brinavess, Merck & Co, Syncrest, merck sharp and dohme
European regulators have given the green light for two of Merck & Co’s new drugs, licensing its anti-psychotic treatment Sycrest and cardiovascular drug Brinavess.
Sycrest (asenapine) is an atypical anti-psychotic that is placed under the tongue to diffuse into the blood.
It is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults and the European ascent following an approval last year in the US, where it is marketed as Saphris.
Eduard Vieta, professor of psychiatry at the University of Barcelona, and director of the Bipolar Disorders Program of the Hospital Clinic, Barcelona, Spain, said: “Bipolar I disorder is difficult to manage, and patients frequently discontinue therapy for a variety of reasons.
“Having multiple treatment options is vital for patients, and asenapine represents a new option for this serious disease,” he added.
The efficacy of Sycrest was demonstrated in two similarly designed, three-week, randomised, double-blind, placebo- and active-controlled monotherapy trials of adult patients who had bipolar I disorder with an acute manic or mixed episode with or without psychotic features.
Sycrest showed superior efficacy to placebo in the reduction of manic symptoms over three weeks with a statistically significant difference between the drug and placebo seen at an early stage.
It was generally well tolerated in the all trials with the most common side effects shown to be somnolence and anxiety that affected around 10% of patients studied.
There are already a number of established bipolar treatments on the market, including AstraZeneca’s Seroquel, Lilly’s Zyprexa and J&J’s Risperdal.
In 2003, the FDA required all atypical antipsychotics drugs to carry warnings about the link between the class and an increased risk of developing type II diabetes after a series of lawsuits came out against the treatments.
European approval for Merck’s Brinavess
Meanwhile, Merck also received EU approval for its atrial fibrillation drug Brinavess, which is indicated for non-surgical patients who have a recent onset of atrial fibrillation (AF) and have suffered from AF for seven days or less.
It is also available for heart surgery patients that have experienced AF for three days or less.
There are approximately 2.5 million Americans and 4.5 million people in Europe with AF meaning that this will be a potentially lucrative market for the drug.
The approval of Brinavess is based on the results of three randomised, double-blind, placebo controlled studies and an active comparator trial. The trials tested for safety and efficacy and showed it was significantly more effective than the standard treatment amiodarone.
“This medicine offers physicians, patients and hospitals an important new therapy option to use for the rapid treatment of recent-onset AF, and we are pleased to add this to our strong portfolio of medicines for cardiovascular disease,” said Patrick Magri, general manager of Merck’s cardiovascular franchise.
“We welcome this important milestone in our collaboration with Cardiome and we look forward to launching Brinavess in the EU beginning in the fourth quarter of 2010,” Magri added.
Brinavess will be in competition with Sanofi-Aventis’s Multaq, which was approved by the FDA last year and received a limited NICE recommendation for the treatment of AF in August.
Ben Adams
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