LUXEMBOURG – June 26, 2020 –Inceptua Group – pharmaceutical company and service partner spanning throughout the product lifecycle – from clinical trial comparator sourcing, packaging, labelling, and distribution solutions, through early access and unlicensed medicines programs to licensing and commercialization of products – has announced a partnership with BioCryst Pharmaceuticals, Inc. on an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with hereditary angioedema (HAE) in the United States.
Through this program, physicians may be able to request berotralstat for HAE patients who do not have access to the product through a clinical trial.
Mark Corbett, Executive Vice President, Inceptua Medicines Access said:
“We are pleased to be supporting BioCryst in helping patients diagnosed with hereditary angioedema through this expanded access program in the United States. Helping healthcare professionals to access pre-approval treatments such as berotralstat for their patients with unmet need is one of Inceptua’s expertise areas.”
According to the U.S. Food and Drug Administration (FDA), expanded access is a pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials, when no comparable or satisfactory alternative therapy options are available.
Requests for expanded access to berotralstat must be made by a U.S. licensed physician. Physicians can request access for a patient by sending an email to email@example.com or calling 1-888-225-8677.
A new drug application for berotralstat is currently under review by the FDA with an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).
Inceptua is a pharmaceutical company and service partner spanning throughout the product lifecycle – from clinical trial comparator sourcing, packaging, labelling, and distribution solutions, through early access and unlicensed medicines programs to licensing and commercialization of products.
Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience:
- Inceptua Pharma commercializes and market orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally
- Inceptua Services supports pharma and biotech companies with global clinical trial comparator sourcing, packaging and labelling solutions, pre-approval and medicines access programs and consulting Inceptua has global operations with local offices across Europe, USA, and Asia.
For further information, please contact:
Mark Corbett Executive Vice President, Inceptua Medicines Access
Direct: +44 20 39107 641
Morten Grøn, Inceptua Communications
Mobile: +45 2556 4781