trending Market Intelligence /marketintelligence/en/news-insights/trending/BJGcYsD-I6AX_Te8uqx4Gg2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Celgene therapy for bone marrow disorder wins US FDA approval

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform

Celgene therapy for bone marrow disorder wins US FDA approval

Celgene Corp.'s life sciences arm Impact Biomedicines Inc. gained U.S. Food and Drug Administration approval for Inrebic to treat a rare bone marrow disorder.

Inrebic, or fedratinib, is the second such medicine the FDA has approved for myelofibrosis. This rare form of bone marrow cancer harms the body's ability to produce blood cells for healthy living. Incyte Corp.'s Jakafi was the first medicine approved for the disease in the U.S. in 2011.

Celgene's treatment is approved for patients with intermediate or high-risk myelofibrosis. The approval is based on results of a phase 3 study called Jakarta. About 36.4% of patients exhibited a 35% or greater reduction in spleen volume after six, one-month treatment cycles. About 37.5% of patients showed a 50% or greater reduction in overall symptoms, such as night sweats, itching, abdominal discomfort and bone or muscle pain.

SNL Image

The FDA accepted the marketing application for Inrebic in March and granted it priority review. The U.S. regulator previously granted the therapy orphan drug designation, which would give the medicine market exclusivity for a certain period now that it is approved.