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Published on 24 May 2013

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Positive late-stage results for fasiglifam

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Takeda’s recently announced positive late-stage results for new type 2 diabetes drug, fasiglifam, has prompted excitement within the industry and raised hopes of reviving Takeda’s diabetes treatment business, following last year’s patent expiration of hit product Actos.
But as drugs continue to improve without the addressing the biggest unmet needs of the current therapy landscape, an analyst with GlobalData asks, are we entering an era without blockbuster diabetes drugs?
Dr Valentina Gburcik, Cardiovascular & Metabolic Disorders Analyst for the research and consulting firm, argues that while Takeda’s new drug shows promise, the lack of treatments tackling the condition’s root cause may result in the underwhelming market performance of individual drugs:
“We are entering an era in the diabetes market where the first-in-class drugs start in many ways to resemble ‘me-too’ drugs, despite their novel mechanisms of action. With some of the diabetes drugs going off patent, the prospect for future diabetes blockbusters becomes even bleaker due to eventual generic competition to the former blockbusters, and consequently, even more pronounced cost-effectiveness issues,” says Dr Gburcik.
Fasiglifam – the first GPR-40 agonist to reach late-stage development – has the potential to be a compelling therapeutic option and will likely be investigated for use in combination therapy, given its unique mechanism of action, but GlobalData’s analyst believes this may no longer be enough to achieve the market success of its forbearers:
“We have witnessed the emergence of several drugs in the type 2 diabetes space that have had enormous success and have achieved blockbuster status. However, how long will it be until the market becomes too saturated with drugs having a novel mechanism of action, if those drugs are no longer bringing a high degree of differentiation in terms of addressing the greatest unmet clinical needs in type 2 diabetes, such as sustainable glycemic control?” asks Dr Gburcik.
Takeda is currently preparing for a Phase III study to evaluate the efficacy and safety of fasiglifam in combination with Merck’s Januvia. GlobalData believes that this combination holds great potential, given each drug’s respective distinct mechanism of action, oral route of administration and good safety profile.
“Fasiglifam, together with the other contenders in Takeda’s pipeline, will contribute to the revival of the company’s diabetes business in the post-Actos era; however, the golden times are unlikely to return in the foreseeable future,” concludes Dr Gburcik.


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