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New formulations of Pralia and Enbrel head list of new drugs in Japan

Regulator backs medicines from Pfizer, Takeda, Daiichi Sankyo, Astellas, Zeria and otsuka

Japan flagThere has been a flurry of new product launches, approvals and submissions in Japan in the last couple of weeks, including new formulations of Pfizer/ Takeda's arthritis treatment Enbrel and Daiichi Sankyo's denosumab for osteoporosis.

Pfizer and Takeda officially launched a 50mg pen injection formulation of Enbrel (etanercept) for rheumatoid arthritis on June 10 as a complement to the current syringe version, which has been on the market in Japan since 2005. It is designed to make administration of the drug easier for patients and healthcare staff while reducing the risk of needlestick injuries.

Daiichi Sankyo launched a 60mg subcutaneous syringe formulation of denosumab for osteoporosis yesterday under the Pralia brand name, adding to the 120mg formulation of the product, called Ranmark, which was made available in Japan last year for bone complications stemming from multiple myeloma and bone metastases from solid tumours. The drug is a human monoclonal antibody targeting RANKL, a mediator of bone resorption, and is licensed from Amgen. Daiichi Sankyo is also carrying out phase III trials of denosumab in rheumatoid arthritis.

Astellas and partner Zeria launched Acofide (acotiamide hydrochloride hydrate), a treatment for functional dyspepsia, on June 6. This is the first time the product has been made available anywhere in the world, according to its developers. Acofide works by inhibiting peripheral acetylcholinesterase enzymes which helps alleviate the symptoms of functional dyspepsia, such as impaired gastric motility and delayed gastric emptying. It is the first drug to be specifically approved for this indication in Japan.

Astellas also added to its cardiovascular product range at the end of May with the launch of a new Micamlo (telmisartan 80mg and amlodipine 5mg) formulation, billed as Japan's first high-dose combination of an angiotensin receptor blocker (ARB) and calcium channel blocker (CCB).  The established version of the drug contained 40mg telmisartan and the same dose of amlodipine, and the line extension - which like its predecessor will be co-promoted by Nippon Boehringer Ingelheim - is expected to provide better control of high blood pressure over 24 hours.

Finally, Otsuka Pharmaceutical has had a fertile few weeks with the launch of a new 7.5mg dose of vasopressin receptor antagonist Samsca (tolvaptan) for managing volume overload in patients with heart failure, and approval of a new indication - partial-onset seizures in paediatric patients with epilepsy aged four years and older - for its E Keppra (levetiracetam) product. Until now the latter drug had only been licensed for use in adults. Meanwhile, Otsuka says it filed for approval in Japan for tolvaptan as a treatment for the rare, hereditary disorder autosomal dominant polycystic kidney disease (ADPKD).

12th June 2013

From: Sales



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