FDA Roundup: Generic Rosuvastatin, Psoriasis Recommendation, Dry Eye
Physicians should be aware of several new FDA approvals:
The US Food and Drug Administration (FDA) has approved 8 generic forms of Crestor, (rosuvastatin calcium) for the treatment of high cholesterol in adults.
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Because the drug had previously been approved to treat children with homozygous familial hypercholesterolemia, a rare disease, its manufacturer had argued that it should be protected from any generic competition under the Orphan Drug Act. This petition was denied by a federal judge, allowing the FDA to approve the 8 generics.
The generics are currently on the market.1
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee has recommended approval for the psoriasis drug brodalumab, despite concerns about the potential for suicidal thoughts or actions with the drug.
Out of 6200 patients who took brodalumab during 6 separate trials, 6 suicides were reported. However, those who took the drug for psoriasis saw significant improvement in symptoms, which prompted panel members to vote in favor of the drug.
However, the FDA still has to evaluate the benefits and risks of brodalumab and decide whether to approve the drug—a decision to be made by November 16, 2016.
“I am very pleased that the Advisory Committee has recommended that this life-changing treatment should be available to psoriasis patients who require a treatment with brodalumab's unique mechanism of action,” said Mark Lebwohl, MD, chairman of the Dermatology Department at Mount Sinai School of Medicine in New York, New York, in a statement.3
Xiidra: Dry Eye Disease
The FDA has approved Xiidra (lifitegrast ophthalmic solution) for the treatment of dry eye disease. It is in a new class of drugs called lymphocyte function-associated antigen 1 (LFA-1) antagonists and is the first medication in this category to be approved by the FDA.
To investigate the safety and efficacy of the eye drops, 4 studies were conducted that included more than 1000 patients aged 19 to 97 years. Patients were randomly assigned to use either Xiidra or placebo eye drops twice a day for 12 weeks.
Those who used Xiidra saw more improvement in the signs and symptoms of dry eye than those who used the placebo. Reported adverse effects were mild, including eye irritation, discomfort or blurred vision, and dysgeusia.
“Normal tear production is needed for clear vision and eye health,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide a new treatment option for patients with dry eye disease.” 2
- Pollack A. Generic Crestor wins approval, dealing a blow to AstraZeneca [published online July 20, 2016]. New York Times. http://www.nytimes.com/2016/07/21/business/generic-crestor-wins-approval-dealing-a-blow-to-astrazeneca.html. Accessed July 20, 2016.
- Ault A. FDA panel backs approval of psoriasis drug brodalumab [published online July 20, 2016]. Medscape. http://www.medscape.com. Accessed July 20, 2016.
- FDA approves new medication for dry eye disease [news release]. Silver Spring, MD: US Food and Drug Administration; July 12, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510720.htm. Accessed July 20, 2016.