Actelion's ($ATLN) Tracleer was recommended by Japan's Pharmaceutical Affairs and Food Sanitation Council (PAFSC) for an additional indication aimed at reducing ulcers in patients with generalized scleroderma, a spokesman for the Ministry of Health Labor and Welfare said.
The committee met on July 31 to review Tracleer, designated as an orphan drug for the indication, as well as inhalation therapy INOflo from INO Therapeutics for an additional indication for improving pulmonary hypertension in the perioperative period of heart surgery. The additional indication for INOflo was approved.
PAFSC also received a report on July 31 on Daiichi Sankyo's hypertension treatment Artist for an additional indication of tachycardia atrial fibrillation, and on Novo Nordisk's ($NVO) Tresiba FlexTouch/PenFill (recombinant insulin degludec) for a pediatric dosage.
PAFSC also said a new dosage will be added to the Exelon Patch from Novartis ($NVS) at 9 milligrams daily with a one-step escalation to 18 milligrams after four weeks.
The one-step escalation has been approved overseas, but a three-step escalation is used only in Japan.
The additional pediatric dosage was recommended for the Novo Nordisk FlexTouch/PenFill application as well.
- here's the MHLW site