FDA approves three Takeda diabetes drugs; expands use of Novartis' Gleevec and Pfizer's Prevnar 13

28 January 2013

In what was a busy news day for the US Food and Drug Administration, the agency on Friday approved three new related products from Japan’s largest drugmaker, Takeda Pharmaceuticals (TYO: 4502), for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin), Kazano (alogliptin and metformin hydrochloride) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are already FDA-approved for the management of type 2 diabetes. As the most common form of the disease, type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the USA. The fixed-dose combination therapy alogliptin/pioglitazone suffered a setback last year, when the FDA issued another complete response letter (a first rejectioin came in 2009) further delaying approval of the drug (The Pharma Letter April 26, 2012).

Clearance of the three new products will provide Takeda with a new revenue source as it deals with the patent expiry of its blockbuster diabetes drug Actos (pioglitazone) which, in the fiscal year to March 2011, generated sales of $4.5 billion, around 27% of the firm’s total sales. Nesina faces fierce competition from a number of DPP-4 inhibitors already on the market, led by Merck & Co's Januvia (sitagliptin) as well as Bristol-Myers Squibb/AstraZeneca’s Onglyza/ Kombiglyze (saxagliptin) and Novartis’ Galvus (vildagliptin).

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical