Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Sign in
Sign in

EC approves Basilea's isavuconazole to treat invasive aspergillosis and mucormycosis


The European Commission (EC) has approved Basilea Pharmaceutica's isavuconazole (Cresemba) product to treat invasive aspergillosis and mucormycosis.

The company plans to start a commercial launch of the drug in major European countries in early next year.

Earlier this year, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the regulatory approval of isavuconazole in the European Union (EU) for the treatment in adults with invasive aspergillosis and mucormycosis in patients for whom amphotericin B is inappropriate.

The marketing authorization for isavuconazole will be valid in all 28 EU member states, as well as in Iceland, Liechtenstein and Norway.

Isavuconazole is an intravenous and oral broad-spectrum antifungal used to treat invasive fungal infections, which occur mostly in immunocompromised patients such as cancer patients undergoing chemotherapy.

Basilea Pharmaceutica CEO Ronald Scott said: "The European approval of Cresemba for the treatment of invasive aspergillosis and mucormycosis is a key milestone for Basilea.

"It provides us with the unique opportunity to launch Cresemba as our second hospital anti-infective in Europe and offers an important new therapeutic option to healthcare professionals and their patients suffering from these life-threatening fungal infections."

The US Food and Drug Administration has already approved isavuconazole for patients 18 years of age and older to treat invasive aspergillosis and invasive mucormycosis.

Outside the US, isavuconazole is an investigational product and currently not approved for commercial use.

PBR Staff Writer

Published 19 October 2015

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/

0
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote

We use "cookies*  to ensure the functionality of our website, recognise your browser or device, learn more about your interests, and provide you with essential features and services and for additional purposes, including:

Recognising you when you sign-in to use our services. This allows us to provide you with product recommendations, display personalised content, and provide other customised features and services.
Keeping track of your specified preferences. You may set your preferences through Your Account..
Keeping track of items stored in your shopping basket and personal cabinet.
Conducting research and diagnostics to improve ChemDiv’s content, products, and services.
Delivering content, including ads, relevant to your interests on ChemDiv’s site
Reporting. This allows us to measure and analyse the performance of our services.

By  cookies you give consent to the processing of your personal data, including transfer to third parties. Further information can be found in our privacy policy.

Accept all cookies