A flurry of new product approvals and filings in Japan includes drugs for pulmonary arterial hypertension, H pylori gastritis, Parkinson’s/restless legs syndrome, breast cancer, carnitine deficiency and sedation during dentistry.
Otsuka Pharmaceutical has been given a green light in Japan for Neupro Patch (rotigotine) as a treatment for Parkinson’s disease and restless legs syndrome. It is the first transdermal dopamine agonist product to be approved for sale in Japan – providing a clinically-effective blood drug concentration via stable drug delivery throughout a 24-hour period – and will be launched on February 26, said the company. Outside Japan the products is sold by Belgium’s UCB.
Actelion has been granted approval in Japan for epoprostenol ACT as a treatment for pulmonary arterial hypertension (PAH). The new product is an improved formulation of epoprostenol – a well-established drug for PAH – that offers greater stability and is easier to prepare and administer to patients. The product is already sold as Veletri in the US and has also been approved in Canada and Switzerland, with regulatory review ongoing in Europe.
Takeda and partners AstraZeneca, MitsubishiTanabe and Astellas have been given approval for a new indication for Helicobacter pylori eradication regimens based on a proton pump inhibitor, amoxicillin hydrate and either clarithromycin or metronidazole. The new approval means eradication regimens using products sold by the partners can be reimbursed as treatments for gastritis caused by H. pylori, before complications such as gastric and duodenal ulcers, gastric cancers and idiopathic thrombocytopenic purpura (ITP) develop. Approval of this additional indication will “significantly contribute to the prevention and treatment of diseases related to H. pylori“, according to the partners.
Chugai Pharmaceutical has filed for approval of trastuzumab emtansine (T-DM1) – originally developed by Roche/Genentech as a follow-up to their Herceptin (trastuzumab) blockbuster – for the treatment of HER2-positive metastatic or recurrent breast cancer. Chugai has commercialisation rights to the dug in Japan. Roche and Genentech have already filed for approval of T-DM1 in Europe and the US, with the FDA due to deliver its verdict next week.
Astellas is seeking approval to extend the indications for its Dormicum (midazolam) injectable sedative to include conscious sedation in dentistry and dental surgery. The drug is already approved as for premedication prior to general anaesthesia and for sedation during artificial respiration in critical care.
Meanwhile, Otsuka also says it will launch two new formulations of its L-Cartin (levocarnitine) product for carnitine deficiency next week following approval by Japan’s Ministry of Health, Labour and Welfare (MHLW). At the moment the L-Cartin is only available as an oral tablet, but Otsuka will now add an oral solution and an injectable product to the range. Carnitine deficiency occurs in patients with inborn errors of metabolism and in haemodialysis patients, and can causes symptom such as muscle pains or hypoglyacaemic coma in severe cases.