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Orphan Drugs: Bayer Receives FDA Approval

November 22, 2013

The FDA announces November 22 that orphan drug Nexavar (Sorafenib) receives approval for the treatment of patients with late-stage (metastatic) differentiated thyroid cancer. Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals.

FDA Regulatory Actions for Thyroid Cancer Indication

•   In December 2011, receives Orphan Drug Designation (ODD)

•   In August 2013,  receives Priority Review for supplemental New Drug Application (sNDA)

•   In November 2013, receives approval.

The FDA completes its review of Nexavar’s new indication under the agency’s Priority Review Program. A Priority Review designation means that the FDA will take action on a drug application within 6 months, as opposed to 10 months under standard review. If the drug in question is approved, then it will bring “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The FDA decides on the Priority Review designation for every application – the sponsor can also request Priority Review. The regulatory agency informs the sponsor of a Priority Review within 60 days of the original BLA (Biologics License Application), NDA (New Drug Application), or efficacy supplement.

Differentiated thyroid cancer is the most common type of thyroid cancer. In 2013, in the United States, approximately 60,000 will be diagnosed with thyroid cancer and 1,850 will die. Nexavar is for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that doesn’t respond to radioactive iodine treatment.

FDA regulatory actions for Nexavar :

Kidney Cancer

•   In 2004, receives ODD

•   In 2005, receives approval.

Liver Cancer

•   In 2006, receives ODD

•   In 2007, drug label expands to treat unresectable liver cancer.

A fourth FDA orphan drug indication is granted in 2006 :

Generic   Name:


Trade   Name:


Date   Designated:


Orphan   Designation:

Treatment of stage IIB through   stage IV melanoma

Orphan   Designation Status:


FDA Orphan Approval Status:

Not FDA Approved for Orphan   Indication


Bayer Pharmaceuticals Corp.
P. O. Box 1000
Montville, NJ 07045-1000The sponsor address listed is the   last reported by the sponsor to OOPD.

Please Note: FDA Official Logo from FDA website.

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