December 11, 2008
Novartis Pharmaceuticals Corporation and Schering-Plough Statement on Food and Drug Administration's Joint Advisory Committee recommendation regarding medicines containing long-acting beta2-agonists for the treatment of asthma
Novartis and Schering-Plough strongly disagree with the Joint Advisory Committee's view that the benefits of FORADIL do not outweigh its risks in patients using it according to current product labeling for the maintenance treatment of asthma. We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of FORADIL in patients not adequately controlled on other asthma-controller treatments.
Novartis and Schering-Plough remain confident in the safety and efficacy of FORADIL AEROLIZER (formoterol fumarate inhalation powder) in the maintenance treatment of asthma. Patient safety is a primary concern at Schering-Plough and Novartis, and the companies will work closely with the FDA as the agency considers the Joint Advisory Committee recommendation to determine appropriate next steps.
As we heard from representatives of professional and patient organizations today, access to single-agent LABAs provides physicians with the ability to develop customized treatment approaches that best meet the needs of their patients. FORADIL enables physicians to step-up treatment in patients who are not controlled on an ICS, then step-down once control has been achieved. FORADIL also can be added to any of the approved inhaled corticosteroid (ICS) monotherapies, allowing physicians to pair formoterol with either MDI or dry powder inhalers. When used according to current labeling, FORADIL has been shown to improve lung function and symptoms in patients and reduce the need for rescue medication.
LABAs are an important asthma treatment option for adults and children. In a significant number of asthma patients, treatment with ICS does not lead to control of asthma symptoms. The National Heart Lung and Blood Institute's Guidelines for the Diagnosis and Management of Asthma recommend LABAs as a preferred step-up therapy for patients whose disease cannot be managed with ICS alone.
People who are taking FORADIL for the treatment of asthma or COPD should contact their healthcare professional if they have questions about their treatment regimens. Patients currently being treated for asthma should not make changes to their treatment regimen except with the explicit advice of their doctors. Information about asthma and asthma management is available on the Web sites of Allergy and Asthma Foundation of America (AAFA) at www.aafa.org and Allergy & Asthma Mothers Network of Asthmatics (AANMA) at www.aanma.org.
Contacts:
Novartis Pharmaceutical Corp. US Communications
Maureen Byrne
862-778-1518 (office)
973-714-0063 (cell)
maureen.byrne@novartis.com
Schering Plough Global Product Communications
Julie Lux
908-298-4774 (office)
908-216-0370 (cell)
julie.lux@spcorp.com