News
International Approvals: Canada, EU, Israel, Norway, Iceland
Anagrelide HCl has been approved in the European Union (EU) as a second-line therapy for essential thrombocythemia.
Darifenacin HBr has been approved in the EU, Norway, and Iceland for the treatment of overactive bladder. Docetaxel has been approved in the EU for use in combination with prednisone for the treatment of refractory metastatic prostate cancer. The Animas IR 1200 insulin pump has been approved in Canada and Israel. A 625-mg dose of nelfinavir mesylate has been approved in Canada.
Anagrelide (Xagrid) Approved in EU for Essential Thrombocythemia
On Nov. 19, the European Commission (EC) approved anagrelide HCl (Xagrid capsules, marketed as Agrylin in the U.S., made by Shire Pharmaceuticals plc) for use in the European Union (EU) as second-line monotherapy for essential thrombocythemia.
Anagrelide therapy is intended for use in reducing the elevated platelet counts of patients that are intolerant of, or nonresponsive to, standard therapy. In doing so, it is intended to reduce the risk of thrombosis and ameliorate associated symptoms, including thrombohemorrhagic events.
Anagrelide had been granted orphan drug status by the EC in December 2000. It was approved for this indication by the U.S. Food and Drug Administration (FDA) in December 1998.
Darifenacin (Emselex) Approved for Overactive Bladder in EU, Norway, and Iceland
On Oct. 27, the European Commission (EC) approved darifenacin HBr (Emselex, made by Novartis Pharma AG) for use in the European Union (EU) in the treatment of overactive bladder (OAB). Darifenacin was also approved for use in Norway and Iceland.
The M3-selective receptor antagonist selectively inhibits the detrusor muscle that controls bladder contractions, sparing the M1 and M2 receptors thought to be associated with central nervous system and cardiovascular functions.
The approval was based on the results of clinical trials showing that darifenacin reduced the number of weekly incontinence episodes by 72% compared with placebo. Therapy with darifenacin also significantly improved other key symptoms of OAB, including frequency of voiding, bladder capacity, and severity of urgency.
In the trials, darifenacin therapy did not impair cognitive function or result in adverse cardiovascular effects.
According to a company news release, the drug also has the potential to prolong "warning time" — the period between the first sensation of urgency and micturtion — in patients with OAB.
Darifenacin (Enablex, made by Novartis) was previously approved for use in Canada and is currently under review by the FDA.