FDA Approves New Indication for COPD Drug
Spiriva – Asthma
The FDA has approved Spiriva Respimat (tiotropium bromide) for the long-term, once-daily maintenance of asthma in individuals 12 years old and older.
Spiriva, which is already approved for the treatment of chronic obstructive pulmonary disease, is not indicated for treatment of sudden asthma symptoms.
The drug, which is steroid free, is part of a new class of asthma medications called long-acting muscarinic antagonists (LAMAs).
The efficacy and safety of the drug were evaluated in 12 clinical trials of roughly 5000 adults and adolecents with asthma were currently being treated with an inhaled corticosteroid. Researchers found that adding Spiriva to individuals’ treatment significantly improved lung function and reduced exacerbations compared to placebo.
The most common side effects of Spiriva include sore throat, sinus infection, bronchitis, and headache.
Clozapine – Blood Disorder Warning
The FDA has changed the requirements for prescribing, dispensing, and receiving the schizophrenia medication clozapine due to growing concerns of the risk of developing neutropenia, a serious blood condition in which an individual lacks adequate levels of certain infection-fighting white blood cells.
“In order to prescribe and dispense clozapine, prescribers and pharmacies will be required to be certified in the Clozapine risk evaluation and mitigation strategy (REMS) Program according to a specific transition schedule starting October 12, 2015.”
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The FDA has also clarified and enhanced prescribing information found on the drugs label, stressing that patients taking the drug should be monitored for severe neutropenia by way of regular absolute neutrophil count checks.
“The revised prescribing information and the Clozapine REMS Program will improve monitoring and management of patients with severe neutropenia. The shared REMS is also expected to reduce the burden and possible confusion related to having separate registries for individual clozapine medicines,” they wrote.
Vraylar – Biopolar Disorder and Schizophrenia
The FDA has approved Vraylar (cariprazine) for the treatment of schizophrenia and biopolar disorder in adults.
The safety and efficacy of Vraylar in the treatment of schizophrenia and bipolar disorder were assessed in 3 6-week trials including 1754 participants and 3 3-week trials of 1037 participants, respectively, in which the drug was shown to reduce the symptoms of both disorders when compared to placebo.
Vraylar carries a boxed warning of an increased risk of death in older adults with dementia-related psychosis. The most common side effects include tremor, slurred speech, akathisia, indigestion, vomiting, and restlessness.
1. Boehringer Ingelheim. FDA approves Boehringer Ingelheim’s SPIRIVA RESPIMAT for the maintenance treatment of asthma in adults and adolescents [press release]. September 16, 2015. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/fda-approves-boehringer-ingelheims-spiriva-respimat-maintenance-treatment-asthma-adults-adolescents.html.
2. FDA. Clozapine: drug safety communication - FDA modifies monitoring for neutropenia; approves new shared REMS program [press release]. September 15, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm462229.htm.
3. FDA. FDA approves new drug to treat schizophrenia and bipolar disorder [press release]. September 17, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm463103.htm.