Evicenter
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Atebrioz (zilurgisertib)

Fibrodysplasia ossificans progressiva

Also known as INCB000928
Regulatory submission
NDA submitted by May 2026
Last updated
96 sources

Product information and disease descriptionProduct descriptionProduct information

Access and distribution

4 evidence topics · 5 sources

Commercial availability, patient support program, and out-of-pocket cost

“Atebrioz will be available through Mirum Access Plus (MAP), a patient support program designed to help patients, families and healthcare providers navigate treatment access. MAP provides insurance coverage and access support, financial assistance for eligible patients, personalized patient support and educational resources for patients and caregivers. Atebrioz is expected to be commercially available in the U.S. in October, with eligible patients paying as little as $0 per month through MAP. To learn more about MAP, call 855-MRM-4YOU (1-855-676-4968).” (opens the source at this quote in a new tab)

Mirum Access Plus services for patients and prescribers

“MAP is a support program with a dedicated team that helps patients, caregivers, and their healthcare providers access medication and connect with helpful resources.” (opens the source at this quote in a new tab)

“We've built a portal that provides access to real-time information on your patient's coverage and fulfillment journey.” (opens the source at this quote in a new tab)

Specialty pharmacy distribution of the manufacturer's approved medicines

“The Company relies on a single third-party logistics provider (“3PL”) and a single specialty pharmacy for all of the Company’s sales of its approved medicines in each of the U.S. and Canada as well as a single 3PL outside of North America.” (opens the source at this quote in a new tab)

Preapproval compassionate use and continued access for trial participants

“However, individuals with FOP, ages 12 and over, living in the United States, may be able to use zilurgisertib through a new Compassionate Use Program opened by Mirum and Incyte.” (opens the source at this quote in a new tab)

“There are no planned changes to the conduct of the PROGRESS study as a result of this agreement including the open label extension period, and current study participants will not lose access to zilurgisertib.” (opens the source at this quote in a new tab)

Risk evaluation and mitigation strategy

No evidence found.