CINQAIR was approved by FDA for use with other asthma medicines so that severe asthma in patients over 18 years of age can be treated, as per a report dated March 25, 2016.
Manufactured by Teva Support Solutions, this treatment would be available to patients commercially by prescription during the 2nd quarter of 2016.
Director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA, Badrul Chowdhury stated that patients and health care providers will have a new option for Asthma in case it doesn’t get cured with current asthma therapies.
CINQAIR can be administered through an intravenous infusion ever four weeks, and it is manufactured by recombinant DNA technology in murine myeloma non-secreting 0 cells.
It lowers the levels of blood eosinophils, a white blood cell type which has an impact on the development of asthma, thereby decreasing severe asthma attacks.
FDA has approved it owing to the safety and efficacy of data of 4 double-blind, placebo-controlled and randomized trials which included patients with severe asthma on therapies that are currently available.
As per the data, it was indicated that patients with severe asthma who were given CINQAIR experienced the longer time to 1st attack and exhibited fewer attacks, as compared to the placebo.
Substantial improvement was seen in lung function measured by volume of air that was exhaled in 1 second.
However, when it comes to CINQAIR treatment, potentially life-threatening side effects can be caused such as allergic reactions.
Talking about the clinical trials, the most common side effects that were observed included muscle pain, cancer and anaphylaxis.
After CINQAIR is available commercially, Teva would provide education, training, and personalized support to patients and healthcare providers.