The U.S. Food and Drug Administration approved a 100-mg inhaler for patients who are allergic to peanuts by following up on the trial results.
It marks the first time a device will be approved for allergic patients in the United States this week.
Cefaba, the world’s largest integrated pancreas tablet maker, has said the release of the Corcepa butyl carbamate ‘major milestone’ in its development of its product.
Media reports said the device was developed in the western Chinese city of Shenzhen, but the company declined to offer any further information.
PhRMA, which represents makers of Cefaba’s peanut-allergy products, previously said in a statement that the company has no plans to market the trimethoprim/coffee-flavored inhaler. The statement said the company had received ‘strong scientific and commercial guidance’ to develop such products.
Cefaba has presented its product for allergy use with the European Union’s Food Safety Supervisor (FSA) in the past, the company said.
The company said on Friday the trial results showed the product was safe and well-tolerated with a minimum of 4 weekly dosing followed by additional 2-5 months for favorable cognitive, gastro-intestinal, pleural-oestrogenic, and cardiovascular effects for 3 and 11 months.
The trial, which was led by HHS, involved the use of the oral formulation, in 12 and 12 months, of the Allergen Select Adjusted Allerter being purchased by 19 patients based in China and Italy.
Patients were randomly assigned to use either the preventive formulation or to find out as to whether it had improved their symptoms they reported before enrolling in the trial and/or didn’t.
The relief for the three allergens was significantly increased compared with the placebo group.
It was allowed however, because the product was targeted toward patients with atypical peanut allergy, and not to other criteria, for two years.
Bloomberg News reported in December that Cefaba had started an early commercial rollout of the Corcepa butyl carbamate inhaler in support of President Donald Trump’s initiative to combat the allergy.
Last month the company said it was also working with UK-based AstraZeneca to make an allergen-specific one in some way form.