The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.

The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.

In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.

The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.

Teva Pharmaceuticals is marketing the drug as Cinqair.

klennon@frontlinemedcom.com

Ads

You May Also Like

Daptomycin beats infective endocarditis caused by several pathogens

AT ECCMID 2016 AMSTERDAM (FRONTLINE MEDICAL NEWS) – Daptomycin successfully treated infective endocarditis in ...

OIG: States provide incomplete picture of Medicaid managed care

Federal auditors are calling on the Medicaid program to withhold money from states that ...

Platelet indexes flag suspected pulmonary embolism

Levels of platelet distribution width (PDW) and mean platelet volume (MPV) were significantly higher ...