Mylan’s Wixela becomes first FDA-approved generic version of GSK’s Advair inhaler

pharmafile | January 31, 2019 | News story | Sales and Marketing Advair, COPD, FDA, Wixela, asthma, generic, pharma 

Mylan’s Wixela has become the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler to be approved in the US.

The twice-daily therapy has secured marketing authorisation for the treatment of asthma in patients aged four years and older as well as the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Mylan’s product was previously rejected by the US agency after initially being accepted for review in 2016, citing “minor deficiencies”. Launch of Wixela is expected in February, with analysts predicting $170 million in sales throughout 2019. Its reference product made $4.1 billion for GSK in 2017.

“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the US is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” commented Dr Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis, added: “The FDA recognises challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this. We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritising review of many applications covering proposed generic complex products for which a generic has not yet been approved.”

Matt Fellows

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