FDA Approves Roflumilast, Generic Version of Daliresp for Severe COPD

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by Marisa Wexler MS |

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The U.S. Food and Drug Administration (FDA) has given final approval to Zydus Pharmaceuticals to start marketing roflumilast tablets at a dose of 500 micrograms (mcg), according to a company press release.

Roflumilast tablets are a generic version of oral Daliresp, manufactured by AstraZeneca. Like the brand-name medicine, these generic tablets are indicated to reduce the risk of exacerbations — episodes of sudden symptom worsening — in people with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.

Generics are therapies that contain the exact same active agents as name-brand medications. Generally, generics can add competition to pharmaceutical marketplaces, incentivizing lowered costs.

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The FDA also gave Zydus tentative approval for a lower dose strength (250 mcg) of the same roflumilast tablets. Of note, a tentative approval is when the FDA delays a final approval until all patent or exclusivity issues have been resolved; it does not allow product marketing, even though efficacy and safety standards have been met.

Because Zydus is among the first applicants for a generic version of roflumilast, the company is eligible to 180 days of shared generic drug exclusivity, basically meaning that no other generic versions of the therapy will be approved during this roughly six-month window.

The newly approved generic will be manufactured at Zydus’ facility in Ahmedabad, India.

Roflumilast works by blocking the activity of a protein called phosphodiesterase 4 (PDE4). This is thought to reduce inflammation, as well as lessening abnormal lung tissue remodeling.

The FDA first approved Daliresp in 2011 based on data from eight clinical trials, which collectively enrolled 9,394 adults with COPD, ages 40 and older.

Results of these studies broadly indicated that treatment with Daliresp could lower the risk of COPD exacerbations, particularly in those with severe disease and bronchitis — inflammation in the bronchial tubes, which carry air to and from the lungs. Trial results also suggested that treatment with Daliresp improved patients’ lung function.

Roflumilast is given at a dose of 500 mcg per day, with or without food. To reduce the risk of tolerability issues, patients may be given a half dose (250 mcg/day) for the first four weeks of treatment.

The most common side effects associated with roflumilast include diarrhea, nausea, weight loss, headache, back pain, flu-like symptoms, trouble sleeping, dizziness, and reduced appetite.