People with asthma now have a new option to breathe easier.
The U.S. Food and Drug Administration this week approved the first generic asthma inhaler as part of its efforts to improve access to lower-cost drug options "that are as safe and effective as their brand name counterparts,” the agency said in a statement.
The first generic form of Teva’s ProAir HFA Inhalation Aerosol (albuterol sulfate) will treat or prevent bronchospasm — a sudden muscle constriction of the airways that leads to shortness of breath, chest tightness, coughing and wheezing.
It’s approved for patients 4 years old or older who have reversible obstructive airway disease or experience bronchospasm triggered by exercise.
About 26 million people in the U.S. have asthma, a disease that affects the lungs, with almost a quarter of them children, the FDA noted. There’s no cure, but the condition can be managed with proper prevention of asthma attacks and treatment. Still, more than 3,500 people die of asthma each year, according to American College of Allergy, Asthma & Immunology.
“This is a big deal because this is the first standalone generic asthma inhaler that the FDA has approved and by that I mean it’s a true generic — it’s one that’s not made by a brand-name company,” said NBC News medical correspondent Dr. John Torres.
“When the brand name companies make it, the price doesn’t necessarily come down. Hopefully, this will drive pricing down.”
Such metered dose inhalers, known as complex generics, are harder to copy because of their complex formulation or mode of delivery, said FDA Commissioner Dr. Stephen M. Hahn in a statement. In other words: It’s not just the medication but the device itself that’s harder to duplicate for a generic version.
“As a result, too many complex drugs lack generic competition,” Hahn noted. “Getting more generic copies of complex drugs to the market is a key priority.”
The brand name inhaler can cost up to $500, Torres said. It’s not known yet how much the generic version will cost, but the price could be driven to below $100, he added.
Many of Torres’ patients are weary of generic drugs, wondering whether they’re as effective as brand-name options. He said he assures them the generic is the equivalent of the regular medicine, with the same active ingredient.
Perrigo Pharmaceutical, the company approved to make the generic asthma inhaler, was “immediately launching” a limited quantity of the device and ramping up production to meet future demand, it said in a statement.
The company expects to provide a steady supply of the product by the fourth quarter of 2020.