FDA approves teen-only anti-inflammatory, calls it ‘significant advancement’

(Photo: Shutterstock) The U.S. Food and Drug Administration on Monday approved Orencia, the first antibody drug approved for patients 12 and younger, to treat patients who have a type of form of CTE. Covidien…

FDA approves teen-only anti-inflammatory, calls it ‘significant advancement’

(Photo: Shutterstock)

The U.S. Food and Drug Administration on Monday approved Orencia, the first antibody drug approved for patients 12 and younger, to treat patients who have a type of form of CTE.

Covidien on Monday announced it has reached a settlement with American Medical Systems, Inc. (AMS) in the suit, which relates to Antenna, which AMS developed and marketed between 2006 and 2009 and was sold in Europe and elsewhere. Financial terms of the settlement were not disclosed.

AMS said in a statement that it would fully implement the terms of the settlement “without re-litigating the various and contested issues.”

FDA’s Orencia approval

The FDA approval gives Orencia an advantage over anti-inflammatories, such as ibuprofen, which are FDA-approved for children 12 and under. People 16 and younger can also take olanzapine, which isn’t FDA-approved for that age group, the agency said.

On Monday, Amgen Inc. said it will pay $3.35 billion to buy South San Francisco, Calif.-based nootropics maker Posit Science Inc. to add treatments for Parkinson’s disease and sleep disorders. Orencia is Amgen’s second-biggest product, by sales, behind Enbrel.

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