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|March 23, 2016 10:57 a.m.|
|Teva Announces FDA Approval of CINQAIR® (reslizumab) Injection|
New Biologic for Add-On Maintenance Treatment in Adults with Severe Asthma and an Eosinophilic Phenotype
CINQAIR® is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.
“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
“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
“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.”
Upon commercial availability of CINQAIR®, Teva will launch Teva Support Solutions℠, a comprehensive program that will provide personalized support, training and education to healthcare providers and patients who have been prescribed CINQAIR®.
This is the first approval of CINQAIR® (reslizumab) anywhere
in the world. Reslizumab has been submitted to and is currently under
Indications and Usage
CINQAIR® (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 Kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, with an eosinophilic phenotype.
Limitations of Use: CINQAIR® is not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
Important Safety Information
Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.
Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.
CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.
In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group.
No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Eosinophils may be involved in the immunological response to some parasitic (helminth) infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.
Adverse reactions that occurred at greater than or equal to 2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).
Please click here for full Prescribing Information, including Boxed
Prior to the availability of full Prescribing Information online, a copy
may be requested from the US Medical Information Contact
About CINQAIR® (reslizumab) Injection
CINQAIR® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa), approved by the
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. The company’s respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of
Teva Pharmaceutical Industries Ltd.