The Food and Drug Administration has accepted Lannett’s abbreviated new drug application for fluticasone propionate and salmeterol inhalation powder in three strengths — a generic of GlaxoSmithKline's Advair Diskus. Lannett submitted the ANDA on behalf of its strategic alliance partner, Respirent Pharmaceuticals.
The FDA accepted the application as a priority original ANDA, assigning it a goal date of Jan. 31, 2022. There already is a generic of the product on the market, manufactured by Hikma. The branded product had a market value of approximately $3 billion for the 12 months endinged April 2021.
[Read more: Hikma resumes launch of generic Advair Diskus]
"The FDA's acceptance of the ANDA submission of generic Advair Diskus brings us one step closer to providing asthma patients an affordable option for this critical medication," said Lannett CEO Tim Crew. "We anticipate more than one FDA review cycle of this opportunity given the inherent complexity associated with a drug/device combination inhalation product. However, our partners at Respirent have assembled a comprehensive application and have expertise in developing and manufacturing dry powder inhalation products, so we believe we are positioned for a potential U.S. launch of the product in calendar 2022."
As previously announced, Lannett entered into an exclusive U.S. distribution agreement for the therapeutical equivalent generic of Advair Diskus of Respirent. Under the agreement, Lannett will commence U.S. distribution of the product after FDA approval and receive a portion of the net profits once it commences distribution of the product. The companies recently extended the term of the agreement to 12 years post commencement of distribution.
Advair Diskus is indicated as a twice-daily treatment of asthma in patients age 4 years old and older and a maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Flovent Diskus is an inhaled corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients age 4 years old and older.
As Lannett awaits approval, Crew said the company has a pipeline that presents several opportunities for the company.
"We have publicly discussed four meaningful and durable market opportunity assets in our pipeline, including two respiratory products, generic Advair Diskus, which is closest to potential commercialization, and Flovent Diskus, or fluticasone propionate powder Inhaler; and two products for the treatment of diabetes, biosimilar insulin glargine and biosimilar insulin aspart," he said. "The clinical development of biosimilar insulin glargine continues to advance, with a possible launch in 2023. Similarly, the development of generic Flovent and biosimilar insulin aspart continue to progress, and both products could potentially launch in 2024."