FDA Approves Teva’s Asthma Drug Cinqair as Add-on Treatment

FDA Approves Teva’s Asthma Drug Cinqair as Add-on Treatment

Teva Pharmaceutical Industries recently announced the approval of Cinqair (reslizumab) injection by the U.S. Food and Drug Administration (FDA) as an add-on maintenance treatment for patients with severe asthma, age 18 and older, and with an eosinophilic phenotype.

Cinqair is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa), that is intravenously administered at a weight-based dose of 3 mg/kg, once every four weeks. Now that it has FDA approval, Cinqair should become available by prescription in the second quarter of this year.

“Despite ongoing treatment with today’s standard of care, many patients with severe asthma remain inadequately controlled, the implications of which can lead to increased exacerbations and hospitalization,” said Prof. Mario Castro of Washington University School of Medicine, Division of Pulmonary and Critical Care Medicine, and lead investigator, in a press release.

“The approval of Cinqair marks an important advancement in the treatment paradigm for asthma as the therapy has demonstrated significant improvement in multiple measures of asthma control. As a practicing physician, I look forward to the opportunity to provide my patients, who have severe uncontrolled asthma and fit the profile for Cinqair, with an option that has the potential to help them achieve control of their disease,” Castro said.

“Teva’s specialty medicines pipeline is centered on developing therapies to address the unmet needs of patients, healthcare providers, caregivers, and payers in our key therapeutic areas of focus,” said Michael Hayden, M.D., Ph.D., Teva’s president of Global R&D and CSO. “We are proud to demonstrate our commitment to advancing the treatment of respiratory disease with the development of Cinqair, a targeted therapy for a specific subset of patients with severe asthma, a disease which can present significant treatment challenges that are not adequately addressed by currently available medicines.”

Cinqair’s FDA approval was based on data retrieved from Teva’s asthma program, in which the treatment met its efficacy and safety endpoints. The development program included five clinical trials in which Cinqair 3 mg/kg was tested in 1,028 adult and adolescent patients with asthma whose disease was inadequately controlled with inhaled corticosteroid-based drugs.

Three of the clinical trials were Phase 3 studies in which patients with asthma also had elevated levels of eosinophils in the blood. Cinqair reduced the rates of asthma exacerbations of up to 59 percent, and improved patients’ symptoms, lung function, and quality of life.

In terms of safety profile, oropharyngeal pain and anaphylaxis were the most commonly observed adverse events from treatment with Cinqair. An imbalance in malignancy, which was diagnosed within less than six months of exposure to Cinqair, was observed in the Phase 3 clinical studies (Cinqair 0.6 percent, and placebo 0.3 percent).

“Teva is committed to delivering innovations in asthma care to help patients, across the spectrum of this heterogeneous disease, achieve improved symptom control and quality of life,” said Rob Koremans, M.D., president and CEO of Teva Global Specialty Medicines. “We are pleased to expand our growing respiratory portfolio with Cinqair in the U.S. With this therapy, we now have the ability to provide a targeted, new treatment option for an underserved patient group, thus helping to address a major unmet need in asthma management.”

Following Cinqair’s market availability, Teva will launch Teva Support Solutions, a program that offers tailored training, education, and support to patients using Cinqair and their healthcare providers.

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