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Nucala (mepolizumab) has been approved for use with other asthma medicines as maintenance therapy for patients aged 12 years and older with a history of asthma exacerbations despite adherence with their current asthma medicines, the U.S. Food and Drug Administration announced Nov. 4.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Nucala is a humanized interleukin-5 antagonist monoclonal antibody that limits severe asthma attacks by reducing the levels of blood eosinophils. Nucala is administered subcutaneously once every 4 weeks by a health care professional.
This innovation in precision medicine is the first and only approved, biologic therapy specifically developed for people with severe asthma with an eosinophilic phenotype, according to a statement from GlaxoSmithKline, the maker of Nucala.
The safety and efficacy of Nucala were established in three double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every 4 weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization or emergency department visits, and a longer time to their first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control, compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in 1 second, the FDA said in their statement.
The most common side effects of Nucala include headache, injection site reactions, back pain, and weakness. Hypersensitivity reactions can occur within hours or days of receiving Nucala.
Nucala (mepolizumab) has been approved for use with other asthma medicines as maintenance therapy for patients aged 12 years and older with a history of asthma exacerbations despite adherence with their current asthma medicines, the U.S. Food and Drug Administration announced Nov. 4.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Nucala is a humanized interleukin-5 antagonist monoclonal antibody that limits severe asthma attacks by reducing the levels of blood eosinophils. Nucala is administered subcutaneously once every 4 weeks by a health care professional.
This innovation in precision medicine is the first and only approved, biologic therapy specifically developed for people with severe asthma with an eosinophilic phenotype, according to a statement from GlaxoSmithKline, the maker of Nucala.
The safety and efficacy of Nucala were established in three double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every 4 weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization or emergency department visits, and a longer time to their first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control, compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in 1 second, the FDA said in their statement.
The most common side effects of Nucala include headache, injection site reactions, back pain, and weakness. Hypersensitivity reactions can occur within hours or days of receiving Nucala.
Nucala (mepolizumab) has been approved for use with other asthma medicines as maintenance therapy for patients aged 12 years and older with a history of asthma exacerbations despite adherence with their current asthma medicines, the U.S. Food and Drug Administration announced Nov. 4.
“This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma,” Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Nucala is a humanized interleukin-5 antagonist monoclonal antibody that limits severe asthma attacks by reducing the levels of blood eosinophils. Nucala is administered subcutaneously once every 4 weeks by a health care professional.
This innovation in precision medicine is the first and only approved, biologic therapy specifically developed for people with severe asthma with an eosinophilic phenotype, according to a statement from GlaxoSmithKline, the maker of Nucala.
The safety and efficacy of Nucala were established in three double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies. Nucala or a placebo was administered to patients every 4 weeks as an add-on asthma treatment. Compared with placebo, patients with severe asthma receiving Nucala had fewer exacerbations requiring hospitalization or emergency department visits, and a longer time to their first exacerbation. In addition, patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control, compared with patients receiving placebo. Treatment with mepolizumab did not result in a significant improvement in lung function, as measured by the volume of air exhaled by patients in 1 second, the FDA said in their statement.
The most common side effects of Nucala include headache, injection site reactions, back pain, and weakness. Hypersensitivity reactions can occur within hours or days of receiving Nucala.
