Press Release: FDA approves Nucala to treat severe asthma
November 04 2015 - 5:45PM
Dow Jones News
FDA NEWS RELEASE
For Immediate Release: Nov. 4, 2015
Media Inquiries: Eric Pahon, 240-402-4177,
eric.pahon@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Nucala to treat severe asthma
The U.S. Food and Drug Administration today approved Nucala
(mepolizumab) for use with other asthma medicines for the
maintenance treatment of asthma in patients age 12 years and older.
Nucala is approved for patients who have a history of severe asthma
attacks (exacerbations) despite receiving their current asthma
medicines.
Asthma is a chronic disease that causes inflammation in the
airways of the lungs. During an asthma attack, airways become
narrow making it hard to breathe. Severe asthma attacks can lead to
asthma-related hospitalizations because these attacks can be
serious and even life-threatening. According to the Centers for
Disease Control and Prevention, as of 2013, more than 22 million
people in the U.S. have asthma, and there are more than 400,000
asthma-related hospitalizations each year.
"This approval offers patients with severe asthma an additional
therapy when current treatments cannot maintain adequate control of
their asthma," said Badrul Chowdhury, M.D., Ph.D., director of the
Division of Pulmonary, Allergy, and Rheumatology Products in the
FDA's Center for Drug Evaluation and Research.
Nucala is administered once every four weeks by subcutaneous
injection by a health care professional into the upper arm, thigh,
or abdomen. Nucala is a humanized interleukin-5 antagonist
monoclonal antibody produced by recombinant DNA technology in
Chinese hamster ovary cells. Nucala reduces severe asthma attacks
by reducing the levels of blood eosinophils- a type of white blood
cell that contributes to the development of asthma.
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 four weeks as an add-on
asthma treatment. Compared with placebo, patients with severe
asthma receiving Nucala had fewer exacerbations requiring
hospitalization and/or emergency department visits, and a longer
time to the 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 one second.
The most common side effects of Nucala include headache,
injection site reactions (pain, redness, swelling, itching, or a
burning feeling at the injection site), back pain, and weakness
(fatigue). Hypersensitivity reactions can occur within hours or
days of being treated with Nucala, including swelling of the face,
mouth, and tongue; fainting, dizziness, or lightheadedness; hives;
breathing problems and rash. Herpes zoster infections have occurred
in patients receiving Nucala. Herpes zoster is the virus that
causes shingles.
Nucala is made by GlaxoSmithKline, in Research Triangle Park,
North Carolina.
For more information:
• FDA Center for Drug Evaluation and Research: Drug Information
• Centers for Disease Control and Prevention: Asthma
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
###
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
November 04, 2015 17:30 ET (22:30 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
GSK (NYSE:GSK)
Historical Stock Chart
From Mar 2024 to Apr 2024
GSK (NYSE:GSK)
Historical Stock Chart
From Apr 2023 to Apr 2024