U.S. health regulators have ordered cash to conduct clinical trials involving a total of 53,000 patients to test the safety of a class controversial inhaled asthma drugs that are already on the market.
The trials are required to demonstrate the safety of the drugs known as beta-agonists to long duration of action (LABAs) when used in combination with inhaled steroids, another class of drugs against asthma, the U.S. Food and Drug Administration, said Friday.
Studied LABAs are AstraZeneca Symbicort, Advair Diskus of GlaxoSmithKline, Merck & Dulera of Co and Foradil of Novartis AG.
LABAs since long the object of FDA as they may increase the risk of seriously worsening asthma symptoms which can lead to hospitalization and death.
The drugs work by relaxing the muscles of the airway to help people breathe and are also used to treat the condition of severe lung, chronic obstructive pulmonary disease
(COPD).
The FDA expects to receive results in 2017 for studies that will begin later this year.
In four of the tests requested by the FDA, each of the LABAs more a corticosteroid is compared with the single steroids in patients 12 years of age and over. These studies should include a total of patients group.
Some of these drugs. as Advair and Symbicort, are combination therapies that include a LABA with a corticosteroid.
The Agency also requested a trial of 6 200 patients more young, aged 4 to 11, using Advair Diskus of Glaxo.
The enormous size of the studies reported that the FDA wants to be completely safe on the safety profile of these drugs, they are used so widely, analyst for Morningstar Damien Conover.
A large study population could pose some financial challenges for cash, he said.
"Glaxo complies with the request of the FDA to implement the study of Phase 4," Glaxo spokesman Lisa Behrens, said the trial of pharmacovigilance.
AstraZeneca said it completed the study efforts Agency and media protocol for addressing questions about the use of the drug.
Novartis said that it was reviewing the requirements issued by the FDA postmarketing surveillance while Merck said that it would have little time a comment.
The FDA issued last June of warnings on LABAs, saying that they should never be used on their own to treat asthma and requested cash to conduct further studies to better understand the safety of the LABAs when used with steroids inhalation.
The Agency has posted the requirements of the study on its Web site at http://www.fda.gov/Drugs/DrugSafety/ucm251512.htm.
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