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CHMP rejects Kyowa Kirin’s Parkinson’s disease drug

Results of eight main studies of drug were 'inconsistent', according to the CHMP

The European Medicines Agency’s (EMA) Comittee for Medicinal Products for Human Use (CHMP) has rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant, despite the treatment being approved in the US.

In the US, the Food and Drug Administration (FDA) approved Nouryant (istradefylline) in 2019 as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing ‘OFF’ episodes.

However, the CHMP refused marketing authorisation for the treatment after determining that the results of eight main studies involving 3,245 Parkinson’s disease patients were ‘inconsistent’

The regulator noted that only four out of the eight studies showed a reduction in ‘off’ time, adding that the effect did not increased with a higher dose of the drug.

So-called ‘OFF’ episodes occur when patients experience a return of their Parkinson’s disease symptoms, which can occur due to a number of triggers.

This includes a delayed onset of response to medication, reduced duration of benefit from a medication or reduced/no efficacy of a dose of medication.

“We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, president of Kyowa Kirin International.

“There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson’s, and we believe that istradefylline offers people living with the condition a chance to regain some control over the management of their ‘OFF’ time. We remain committed to pursuing the registration of istradefylline in the EU,” he added.

When the FDA reviewed the drug, it considered four 12-week, placebo-controlled clinical studies that included a total of 1,143 participants in patients with Parkinson’s disease.

The FDA found that, across these four studies, patients treated with Kyowa Kirin’s drugs experienced a statistically significant decrease from baseline in daily ‘OFF’ time compared to patients receiving placebo.

“First of all, I would like to [thank] those who have contributed to the development of istradefylline,” said Tomohiro Sudo, executive officer, head of global product strategy department at Kyowa Kirin.

“Although unfortunately it is a negative opinion from the CHMP this time, we will continue to think of how we can contribute to people living with Parkinson’s and their families as we do in the US and Japan,” he added.

Article by
Lucy Parsons

26th July 2021

From: Regulatory

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