Pfizer in triple approval

Pfizer has received approval for three new drugs on both sides of the Atlantic.

Sutent (sunitinib), a cancer treatment for patients with gastrointestinal stromal tumours (GIST), was approved by the US Food and Drug Administration (FDA) while Exubera (inhaled human insulin) was approved by both the FDA and European authorities.

The firm has also received a positive opinion recommending marketing authorisation of Lyrica (pregabalin) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Hank McKinnell, Pfizer chairman and chief executive, spoke about the importance of Exubera, which the company has already invested over $1 billion in.

He said: “Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide.

“The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease.”

Figures from the charity Diabetes UK show currently there are 1.8 million people in the UK living with diabetes.

The charity welcomed the decision but pointed out that not all diabetes sufferers would benefit from Exubera

Simon O’Neill, Diabetes UK’s director of care, said: “Being able to replace some of the daily insulin injections with an inhaler will be a great breakthrough for some people with diabetes.

“It could prove to be one of the biggest steps forward since the discovery of insulin in 1923.”

Speaking about the approval of Sutent Dr Steven Galson, director of FDA’s Centre for Drug Evaluation and Research, said: “Today’s approval is a major step forward in making breakthrough treatments available for patients with rare and difficult to treat forms of cancer.

“New targeted therapies such as Sutent are helping FDA expand options for patients for whom there are limited alternatives.”

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