Posted from: Thursday, April 07, 2016 - 11:11 AM - Present

Cinqair Approved for Asthma

March 23, 2016 – The U.S. Food and Drug Administration granted approval to Cinqair (reslizumab) by Teva Pharmaceuticals Industries Lts. Approval for Cinqair indicates the drug as an add-on maintenance treatment for patients 18 years of age and older with severe asthma with an eosinophilic phenotype, with bases of its approval on clinical studies that showed that it reduced asthma exacerbations by up to 59% compared to placebo. The Center for Disease Control and Prevention estimates about more than 22 million Americans have Asthma, causing more than 400,000 hospitalizations each year.

Cinqair is a biologic drug known as an interleukin (IL)-5 antagonist that works by blocking the action of IL-5 which decreases eosinophils, which are white blood cells that contribute to airway inflammation. Similar drugs include, GlaxoSmithKline’s Nucala (mepolizumab), also an IL-5 antagonist that was approved on November 4, 2015, for the same purpose as Cinqair, except for patients 12 years of age and older; and AstraZeneca’s Benralizumab, also an IL-5 antagonist for the treatment of severe asthma that is still in the pipelines. The recommended dose for Cinqair is 3mg/kg administered as an intravenous (IV) infusion every four weeks. Dosage forms available include 100mg/10mL solution in single-use vials. Although pricing information is not yet available, the launch date for the specialty drug has been scheduled for the second quarter of 2016. 

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.

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.

 

Last Updated Monday, June 26, 2017 - 12:19 PM.