Kovaltry Approved for Hemophilia A
March 17, 2016 – The U.S. Food and Drug Administration granted approval to Bayer HealthCare’s Kovaltry (antihemophilic factor (recombinant)), for the treatment and control of bleeding episodes in adults and children with hemophilia A – a rare, chronic, genetic bleeding disorder affecting approximately 16,000 adults and children in the United States. It is caused from insufficient clotting Factor VIII activity, which is a protein in the blood that controls bleeding. Usually patients with this condition experience bleeding episodes that cause pain, irreversible joint damage, and life-threatening hemorrhages. Kovaltry is a full length Factor VIII concentrate, recommended to be used through intravenous (IV) infusions, to prevent bleeds as well as to manage bleeding episodes and to control bleeding associated with surgical or dental procedures. Available dosage forms for Kovaltry include single-use vials containing 250 international units (IUs), 500IUs, 1,000IUs, 2,000IUs, or 3,000IUs of powdered Kovaltry. The dosing and dose frequency for Kovaltry is dependent on the patient’s age, weight, and on whether the dose is for prevention or for treating an acute bleed. Most patients however may require infusions 2 to 3 times per week for routine prophylaxis. Although the pricing information for Kovaltry is not yet available, Bayer plans to launch it within a few weeks, and will be available through a limited network of specialty pharmacies.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.