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Ipragliflozin beats diabetes rivals to Japanese approval

Astellas drug is first SGLT2 inhibitor backed by country’s regulator

Astellas has been granted approval in Japan for diabetes drug ipragliflozin, winning the race to bring a drug in the new SGLT2 inhibitor class to the market.

The Japanese regulatory authorities have cleared ipragliflozin under the Suglat trade name for the treatment of type 2 diabetes, beating rivals Ono Pharmaceuticals/AstraZeneca and Johnson & Johnson who have filed their own SGLT2 inhibitors in Japan in recent months.

The SGLT2 inhibitors are tipped to become a major new treatment class in diabetes as they can be used even in patients with dramatically reduced insulin function. AZ was the first to market with its Forxiga (dapagliflozin) candidate in Europe, while J&J's Invokana (canagliflozin) took pole position in the US.

Astellas said it will manufacture and sell Suglat in Japan alongside co-promotion partner Kotobuki Pharmaceutical.

Meanwhile, in other Japan news:

- Bayer has secured Japanese approval for Adempas (riociguat) as a treatment for patients with inoperable chronic-thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgery. Riociguat - which is the first in a new class of soluble guanylate cyclase (sGC) stimulators - was approved in the US, Canada and Switzerland last year and is currently under regulatory review in the EU.

- Takeda's new malignant lymphoma treatment Adcetris (brentuximab vedotin) has been cleared by the Ministry of Health, Labour and Welfare (MHLW) as an intravenous therapy for patients with CD30-positive relapsed or refractory Hodgkin lymphoma (HL) or anaplastic large cell lymphoma (ALCL). The antibody-drug conjugate (ADC) - which was originally developed by Seattle Genetics - has already been approved in the US, Canada and Europe for HL and ALCL.

- Daiichi Sankyo has been given a green light for Inavir (laninamivir octanoate hydrate) for the prevention of influenza in adults and children. The inhaled neuraminidase inhibitor is in the same class as Roche's Tamiflu (oseltamivir) and GlaxoSmithKline's Relenza (zanamivir) and has been available in Japan as a treatment for influenza since 2010.

- Otsuka Pharmaceutical has filed for approval of its once-monthly intramuscular formulation of antipsychotic Abilify (aripiprazole) as a maintenance treatment for schizophrenia. If approved, it will become the first depot formulation of an antipsychotic in the partial dopamine agonist to reach the market in Japan. The product was launched in the US last year under the Abilify Maintena brand and is due to be introduced in the UK - its first European market - this month.

Article by
Phil Taylor

17th January 2014

From: Sales



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