SK Bio's epilepsy drug gets U.S. FDA exemption from PhIII efficacy step

The new drug development unit of Seoul-based SK Group said its in-house epilepsy treatment candidate YKP3089 has received U.S. FDA permission to skip the efficacy testing stage for upcoming Phase III trials in the United States.

The candidate from SK Biopharmaceuticals, according to a story in the Korea Herald, has proven effectiveness in Phase II trials held in the U.S., Europe and Asia in the past four years, making it eligible for the rarely granted permission. It's a first for the specific therapeutic area.

The Korea Herald, citing an unidentified SK Biopharmaceuticals executive, said the candidate demonstrated "about 55% more effectiveness in treating seizure symptoms among patients who did not respond to existing treatments."

SK Biopharmaceuticals hopes to submit the candidate for full approval in 2018, according to the newspaper, aiming to compete with Belgian drugmaker UCB's Vimpat (lacosamide).

In February, a report said SK Group is in the market to spend upwards of $1 billion to acquire two more European or North American companies to beef up its biopharmaceutical business. The company is close to finalizing at least two deals, each worth up to $500 million, according to a separate report in the Korea Herald.

SK Biopharmaceuticals announced last year it was moving to Phase III trials of a treatment for sleep disorders that would be handled overseas by its partner Jazz Pharmaceutical ($JAZZ).

- here's the story from the Korea Herald
- and a link to on the candidate