Aurobindo gets FDA approval for generic Xopenex
BY DSN STAFF
SILVER SPRING, Md. — The Food and Drug Administration has approved Aurobindo’s generic of Xopenex (levalbuterol inhalation solution). The drug is indicated to treat or prevent bronchospasm in adults, adolescents and children 6 years of age and older with reversible obstructive airway disease.
Aurobindo’s generic will be available in formulations of 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL. The drug had a market size of $130 million for the 12 months ended November 2016, according to QuintilesIMS data.
FDA approves new indication for Genentech’s Lucentis
SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Genentech’s Lucentis (ranibizumab injection). The drug has been approved to treat patients with myopic choroidal neovascularization, which is a complication of severe near-sightedness that can lead to blindness.
“Myopic choroidal neovascularization often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,” Genentech chief medical officer and head of global product development Dr. Sandra Horning said. “With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.”
Myopic CNV is estimated to affect some 41,000 people in the United States. This is the fifth approved indication for Lucentis.
Judge blocks sale of Sanofi’s, Regeneron’s Praluent; companies plan appeal
WILMINGTON, Del. — U.S. District Court Judge Sue Robinson on Thursday issued an injunction on the sale of Praluent, a PCSK9 inhibitor from Sanofi and Regeneron. Amgen, maker of another PCSK9 inhibitor Repatha, filed the request for the injunction in 2016 after a jury found its patent infringement claims against Sanofi and Regeneron valid.
The injunction’s imposition has been delayed for 30 days to allow for a business resolution or appeal and request for expedited review from the Federal Circuit. Sanofi and Regeneron say they plan to appeal the decision.
“We will immediately appeal today's ruling, along with the jury's earlier finding upholding the validity of Amgen's patents,” Sanofi EVP and general counsel Karen Linehan said. “It is our longstanding position that Amgen's patent claims are invalid and that the best interests of patients will be greatly disserved by an injunction preventing access to Praluent.”
Amgen chairman and CEO Robert Bradway said the company was pleased with the decision, noting, “Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”
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