Japan's Chuikyo clears seven NCEs, including Plavix and Femara

Seven New Chemical Entities/11 products, including Urief (silodosin), Plavix (clopidogrel) and Femara (retrozole) were approved at Japan's Chuikyo (the Central Social Insurance Medical Council) general meeting on April 19. These drugs will all be added to the National Health Insurance drug price list on April 28.

Among the newly-approved drugs, Kissei Pharmaceutical's Urief, whose NHI prices for 2mg and 4mg capsules are 51.70 yen ($0.45) and 102.90 yen (205.80 yen per day), respectively, was calculated under the similar efficacy comparison method using Harnal (tamsulosin) of Astellas with the price of 178.90 yen (178.90 yen a day) as a comparator. The drug was granted a premium for usefulness of 10%.

Urief, an alpha-1 receptor blocker, is approved for the treatment of urinary disturbances associated with prostatic hypertrophy. The expected sales of the drug for the first year and at the peak in the 10th year are put at 5.7 billion yen and 37.9 billion yen, respectively, according to data from the Chuikyo.