LUXEMBOURG, Dec. 3, 2020 Inceptua announces that the company has entered into a partnership with Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company focused on discovering, developing and delivering treatments for sickle cell disease (SCD), to make voxelotor (approved in the United States under the trade name Oxbryta®) available via an early access program for SCD patients ages 12 years and older in Europe and other regions outside the United States.
“We are pleased to announce this partnership with GBT. Voxelotor is the first medicine to be approved by the U.S. FDA which has a mechanism of action that targets the underlying cause of sickle cell disease. With this partnership we are supporting patients outside the U.S. with very high levels of unmet need to access a promising new treatment sooner than they would ordinarily be able to,” said Mark Corbett, EVP, Inceptua Medicines Access.
Voxelotor, an oral, once-daily therapy designed to target the underlying cause of SCD, has been approved for use in the USA by the U.S. Food and Drug Administration (FDA), but is not currently approved for use outside of the U.S. GBT has announced its intention to file with the European Medicines Agency (EMA) in order to gain marketing approval within Europe.
Early access programs are a compliant route for access to medicines where a patient has either tried all available treatment options in their country and/or cannot access a clinical trial.
SCD is the name for a group of inherited blood disorders which are characterized by misshapen red blood cells, which result in anemia and pain, increases the risk of infections and strokes and has severe impacts on patients’ quality of life, as well as reducing life expectancy. SCD is estimated to affect around five million people globally.
The Voxelotor Early Access Program is available for patients in Europe and other regions outside the United States and will allow patients to access voxelotor prior to marketing approval and it becoming commercially-available in their countries of residence.
Requests for access to voxelotor must be made by a healthcare professional by contacting Inceptua at: email@example.com
For the six Middle Eastern countries in the Gulf Cooperation Council (GCC), GBT previously announced an exclusive distributorship that references the U.S. approval of Oxbryta to allow for access to the medicine while health authorities conduct their regulatory reviews, thereby obviating the need for this new early access program.
Inceptua Group is a premium global service partner and specialty pharmaceutical company:
- Inceptua Services supports pharma and biotech companies through pre-approval and medicines access programs and global clinical trial comparator sourcing, packaging and labelling solutions.
- Inceptua Pharma commercializes and markets orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally.
Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, and Asia.
For further information, please contact:
Morten Grøn, Vice President, Communications
Mobile: +45 2556 4781