New epilepsy company on the block wins FDA approval for made-in-Korea drug to treat focal seizures
The FDA has ushered the fifth branded drug for partial-onset seizures to the market — in what its maker calls a first for the Korean biopharma industry.
Also known as focal seizures, partial-onset seizures are defined by abnormal electrical activity in one part of the brain (versus the whole brain as in generalized seizures). While the 3 million epilepsy patients have had a swath of both prescription and generic drugs to choose from, as much as 60% continue to report having seizures. The new pill, Xcopri, promises to cut the number of episodes down to zero for some.
“The finding from our clinical trials that upwards of 1 in 5 patients stopped having seizures, had 100% reduction in seizures, is what we think is unique about this drug,” Marc Kamin, CMO of SK Life Science, told Endpoints News ahead of the approval.
SK Life Science is the US subsidiary of SK Biopharmaceuticals, which is, in turn, the drug discovery and development arm of a South Korean conglomerate that ranks 73 on Fortune’s Global 500. Having started out as a textile company, SK Holdings now defines itself as a “maker of greater happiness.”
Their efforts with Xcopri, then cenobamate, began in earnest around 10 years ago. After reviewing pharmacokinetic data on the in-house project, they decided to go it alone and proceed into two Phase II studies that ultimately formed the basis of the US approval.
Between the two studies, 655 adults who had partial-onset seizures with or without secondary generalization were given different doses of the drug or placebo. These were patients who had experienced seizures for an average of 24 years and whose median seizure frequency was 8.5 every 28 days.
In one of the studies that’s since been published, median percentage changes in seizure frequency were -24·0% for the placebo group compared with -35·5% for the 100 mg dose group (p=0·0071), -55·0% for 200 mg (p<0·0001), and -55·0% for 400 mg (p<0·0001), respectively. SK Life Science said the other trial showed a statistically significant 56% reduction in median seizure frequency with the 113 patients on 200 mg, versus a 22% reduction with placebo (n=108).
FDA regulators ended up recommending the 200 mg dose for standard maintenance but allowed that some may need 400 mg daily.
As far as they can decipher, Kamin said, the drug has a dual mechanism of action: It blocks a sodium channel while revving up GABA receptors.
SK Life Science’s commercial team has had close to three years to introduce themselves to patient advocacy groups, physicians and payers, chief commercial officer Sebby Borriello said.
“In the most recent years a lot of products have come out for these orphan indications like Lennox Gastaut, which has 50 to 60,000 patients in the United States,” he noted, but there is still room for new options on a much broader scale.
Xcopri will be priced “competitively” with other branded anti-epileptic drugs, he added, such as UCB Pharma’s Briviact and Eisai’s Fycompa. They tend to be used after patients have tried generics.
The parent company is fully on board and supportive for a launch in the second quarter of 2020 pending DEA scheduling, according to Borriello. The current plan is to eventually market the drug in Korea, Japan and China as well, while partner (and Axovant spinout) Arvelle Therapeutics handles Europe.
“It’s always good to add the muscle and the commitment behind our efforts from a very large organization,” he said.