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Takeda's once-weekly DPP-4 inhibitor cleared in first market

Zafatek’s authorisation one of a flurry of new approvals for a number of firms in Japan

Takeda HQTakeda has become the first company to get approval for a once-weekly DPP-4 inhibitor for diabetes after its Zafatek product was cleared in Japan.

The Ministry of Health, Labor and Welfare (MHLW) has given the nod to Zafatek (trelagliptin succinate) for the treatment of type 2 diabetes, giving it a lead over rival product omarigliptin from Merck & Co which was filed in Japan last November.

Zafatek has the distinction of being the first once-weekly DPP-4 inhibitor to reach the market anywhere in the world, with the potential to improve patient adherence and - potentially - improve blood sugar control and reduce diabetic complications compared to the current short-acting products.

At the moment Merck & Co's once-daily DPP-4 inhibitor Januvia (sitagliptin) is comfortably leading the market with sales of almost $4bn last year although sales have started to slide a little in the face of increasing competition in the category.

There is not much agreement on the sales potential of the new once-weekly drugs, however, as the increased patient convenience has to be set alongside the fact that most patients are prescribed these drugs alongside metformin, which must be taken every day.

Takeda licenses Zafatek from Furiex, which stands to receive royalties and sales-based milestone payments.

Japanese product news in brief

Zafatek's first world approval comes amid a flurry of other regulatory news from Japan, including the following product developments:

- The MHLW has approved Gilead Sciences' Sovaldi (sofosbuvir) for the treatment of genotype 2 hepatitis C virus (HCV) infection with or without compensated cirrhosis in combination with ribavirin.  Sovaldi is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection, and also the first product to be marketed by Gilead in Japan. Of the more than one million people chronically infected with HCV in Japan, 20%-30% have the genotype 2 strain of the virus.

- Otsuka has been given a green light to market a new once-monthly formulation of schizophrenia treatment Abilify (aripiprazole) that has been on the market in the US since 2013 and Europe since 2014 as Abilify Maintena. There are around 710,000 people with schizophrenia in Japan, says the company, and medical costs and costs related to non-employment give rise to annual total cost burdens of approximately $23bn in addition to other societal costs.

Meanwhile, the company has also submitted a marketing application for Keppra (levetiracetam) in the additional indication of adjunctive therapy for generalized tonic-clonic seizures.

- GlaxoSmithKline (GSK) has been given the go-ahead by the MHLW to market its long-acting muscarinic antagonist (LAMA) Encruse (umeclidinium) for chronic obstructive pulmonary disease (COPD). The company also won Japanese approval for acne therapy Duac Combination Gel (clindamycin and benzoyl peroxide) and pneumococcal conjugate paediatric vaccine Synflorix.

- Bayer has been granted approval for magnetic resonance imaging (MRI) agent Gadovist (gadobutrol) injection, which has been on the market since 1998 in Europe and is sold in more than 100 countries worldwide. The product is "the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan," according to Bayer.

- Amgen/Astellas' PCSK9-targeting antibody Repatha (evolocumab) has been submitted to the MHLW for approval as a treatment for high cholesterol. Amgen has also filed the drug in the US, where it is expecting a decision by August 27, as well as in the EU.


Article by
Ben Adams

26th March 2015

From: Sales

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