the US Food and Drug Administration has won approval from Pfizer for a six-month paediatric exclusivity extension for its Lyrica product, its top-selling medicine. The approval followed trials with paediatric epilepsy patients. The decision means the US Food and Drug Administration can expect to earn about half the $3.5bn it made from Lyrica in the US last year. But the approval came as the US Food and Drug Administration lost a UK legal case in which the Supreme Court decided its neuropathic pain patent claims about Lyrica were invalid. The NHS could seek to recover up to £500m ($640m) from the company as a result of the judgment.
Pfizer has won approval from the US Food and Drug Administration for a six-month paediatric exclusivity extension for its Lyrica product, its top-selling medicine. The approval followed trials with paediatric epilepsy patients. The decision means Pfizer can expect to earn about half the $3.5bn it made from Lyrica in the US last year. But the approval came as Pfizer lost a UK legal case in which the Supreme Court decided its neuropathic pain patent claims about Lyrica were invalid. The NHS could seek to recover up to £500m ($640m) from the company as a result of the judgment.