FDA still mum on Onglyza, United wins fourth approval

AstraZeneca is waiting this morning for word of the FDA's decision on its new, and closely watched, diabetes drug Onglyza. The agency was scheduled to deliver a verdict yesterday, but AstraZeneca says they haven't heard anything yet.

Onglyza is immensely important to AstraZeneca. If approved--as analysts widely expect following an expert panel recommendation--it will have its first new drug approval in six long years. Onglyza also has a shot at grabbing a significant slice of the booming diabetes market, cashing in on an improved safety profile. Onglyza would compete with Januvia, another DPP-4 inhibitor which earned $1.4 billion last year.

The agency did OK United Therapeutics' Tyvaso for pulmonary arterial hypertension. Tyvaso is the inhaled version of the drug, which is also available in intravenous and injectable forms. This is the developer's fourth approved product, giving United a group of therapies that it can market in the booming hypertension market.

"We are thrilled to have a fourth approval from the FDA for treatment of this serious cardio-pulmonary condition," said Martine Rothblatt, United Therapeutics chairwoman and CEO. "Tyvaso epitomizes the hopes and dreams we had in forming this company."

- read the report on AstraZeneca from Reuters
- check out the story on United's regulatory win from the Washington Business Journal

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