The European Medicines Agency has recommended the approval of Aspireo Pharmaceutical’s Somatoprim for the treatment of acromegaly, a rare disease that results in excess growth.

The Israeli firm said the Committee for Orphan Medicinal Products gave a positive opinion on an application for orphan medicinal product status for the drug.

If approved, Aspireo would be granted 10 years of marketing exclusivity in the European Union. The company would also benefit from reduced regulatory fees.

Aspireo CEO Carsten Dehning said; "EMA’s decision to recommend Somatoprim for orphan medicinal product status is an important milestone in the development of this drug."

"By this resolution, EMA recognises the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it," added Dehning.

The ongoing clinical Phase Ib study in Switzerland and Phase IIa study in the Ukraine are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients, Aspireo said.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Acromegaly is a syndrome that occurs when the anterior pituitary gland produces excess growth hormone after epiphyseal plate closure at puberty.

The disease most commonly affects middle-aged adults and can result in severe disfigurement, serious complicating conditions and premature death if unchecked.

Image: As compared with the hand of a normal person (left), the hand of a patient with acromegaly (right) is enlarged. Photo: Courtesy of Philippe Chanson and Sylvie Salenave