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Fixed-dose combinations of the inhaled corticosteroid (ICS) fluticasone and the long-acting beta-agonist (LABA) vilanterol have been approved by the Food and Drug Administration for treating asthma in adults, the manufacturer, GlaxoSmithKline, announced on April 30.
Vilanterol, as part of the combination product, is the first new LABA approved for asthma in 15 years and fluticasone-vilanterol is the first once-daily inhaled ICS-LABA combination treatment approved for asthma.
Two strengths have been approved, 100 mcg or 200 mcg of fluticasone with 25 mcg of vilanterol, administered once a day with a dry powder inhaler, for people aged 18 years and older, according to the company’s statement. The products are marketed as Breo Ellipta. In 2013, the 100/25 mcg dose was approved to treat chronic obstructive pulmonary disease.
The company had filed for approval for treating asthma in adolescents aged 12-17 years who were studied in the same trials as adults, but the FDA did not approve the product in this age group. In the statement, GSK said that the FDA issued a “complete response” letter for the younger age group, “stating that the data submitted do not show adequate risk-benefit to support the approval in these patients,” and that more data “would be required to further demonstrate the safety and efficacy in this population.”
(The FDA issues complete response letters to companies when approval is not supported by the company’s application; the agency does not make this information public, but manufacturers often make that information available.)
The FDA decision reflects the recommendations of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which, at a meeting on March 19, voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults. But the panels voted 19-1 that the data did not support approval for adolescents, aged 12-17 years, citing uncertainty about safety and inconsistent efficacy results in this age group; panelists said that a separate safety and efficacy study in adolescents was needed.
As with other LABA products, the prescribing information for Breo Ellipta includes a boxed warning about the increased risk of asthma-related deaths associated with LABAs.
Unlike the LABAs salmeterol and formoterol, vilanterol is not approved for use as a single agent. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma.
Serious adverse events associated with Breo Ellipta should be reported to the FDA’s MedWatch program at 800-332-1088. Prescribing information can be found at www.gsksource.com.
Fixed-dose combinations of the inhaled corticosteroid (ICS) fluticasone and the long-acting beta-agonist (LABA) vilanterol have been approved by the Food and Drug Administration for treating asthma in adults, the manufacturer, GlaxoSmithKline, announced on April 30.
Vilanterol, as part of the combination product, is the first new LABA approved for asthma in 15 years and fluticasone-vilanterol is the first once-daily inhaled ICS-LABA combination treatment approved for asthma.
Two strengths have been approved, 100 mcg or 200 mcg of fluticasone with 25 mcg of vilanterol, administered once a day with a dry powder inhaler, for people aged 18 years and older, according to the company’s statement. The products are marketed as Breo Ellipta. In 2013, the 100/25 mcg dose was approved to treat chronic obstructive pulmonary disease.
The company had filed for approval for treating asthma in adolescents aged 12-17 years who were studied in the same trials as adults, but the FDA did not approve the product in this age group. In the statement, GSK said that the FDA issued a “complete response” letter for the younger age group, “stating that the data submitted do not show adequate risk-benefit to support the approval in these patients,” and that more data “would be required to further demonstrate the safety and efficacy in this population.”
(The FDA issues complete response letters to companies when approval is not supported by the company’s application; the agency does not make this information public, but manufacturers often make that information available.)
The FDA decision reflects the recommendations of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which, at a meeting on March 19, voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults. But the panels voted 19-1 that the data did not support approval for adolescents, aged 12-17 years, citing uncertainty about safety and inconsistent efficacy results in this age group; panelists said that a separate safety and efficacy study in adolescents was needed.
As with other LABA products, the prescribing information for Breo Ellipta includes a boxed warning about the increased risk of asthma-related deaths associated with LABAs.
Unlike the LABAs salmeterol and formoterol, vilanterol is not approved for use as a single agent. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma.
Serious adverse events associated with Breo Ellipta should be reported to the FDA’s MedWatch program at 800-332-1088. Prescribing information can be found at www.gsksource.com.
Fixed-dose combinations of the inhaled corticosteroid (ICS) fluticasone and the long-acting beta-agonist (LABA) vilanterol have been approved by the Food and Drug Administration for treating asthma in adults, the manufacturer, GlaxoSmithKline, announced on April 30.
Vilanterol, as part of the combination product, is the first new LABA approved for asthma in 15 years and fluticasone-vilanterol is the first once-daily inhaled ICS-LABA combination treatment approved for asthma.
Two strengths have been approved, 100 mcg or 200 mcg of fluticasone with 25 mcg of vilanterol, administered once a day with a dry powder inhaler, for people aged 18 years and older, according to the company’s statement. The products are marketed as Breo Ellipta. In 2013, the 100/25 mcg dose was approved to treat chronic obstructive pulmonary disease.
The company had filed for approval for treating asthma in adolescents aged 12-17 years who were studied in the same trials as adults, but the FDA did not approve the product in this age group. In the statement, GSK said that the FDA issued a “complete response” letter for the younger age group, “stating that the data submitted do not show adequate risk-benefit to support the approval in these patients,” and that more data “would be required to further demonstrate the safety and efficacy in this population.”
(The FDA issues complete response letters to companies when approval is not supported by the company’s application; the agency does not make this information public, but manufacturers often make that information available.)
The FDA decision reflects the recommendations of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, which, at a meeting on March 19, voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults. But the panels voted 19-1 that the data did not support approval for adolescents, aged 12-17 years, citing uncertainty about safety and inconsistent efficacy results in this age group; panelists said that a separate safety and efficacy study in adolescents was needed.
As with other LABA products, the prescribing information for Breo Ellipta includes a boxed warning about the increased risk of asthma-related deaths associated with LABAs.
Unlike the LABAs salmeterol and formoterol, vilanterol is not approved for use as a single agent. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma.
Serious adverse events associated with Breo Ellipta should be reported to the FDA’s MedWatch program at 800-332-1088. Prescribing information can be found at www.gsksource.com.
