SK Biopharmaceuticals, the new drug developing unit of South Korea’s SK Group, on Monday said that its self-developed epilepsy treatment YKP3089 has become the first of its kind to skip the efficacy testing stage in its forthcoming phase III clinical trials in the United States.
The U.S. Food and Drug Administration made the rare decision given SK’s new epilepsy treatment has sufficiently proven its effectiveness in the phase II clinical stage held across the U.S., Europe and Asia over the past four years.
The new drug has been “shown to be about 55 percent more effectiveness in treating seizure symptoms among patients who did not respond to existing treatments,” said a SK Biopharmaceutical official.
A treatment’s ability to lower the frequency of a patient’s seizure symptoms determines the FDA’s evaluation and approval of a new epilepsy treatment.
In line with the FDA’s guidelines, SK will skip over the efficacy testing stage and simply pursue safety trials on the drug’s long-term use, significantly cutting down related costs and the testing period.
The company said it plans to submit the drug for commercialization approval to the FDA next year and begin official sales in the U.S. starting from 2018.
SK Biopharmaceuticals believes YKP3089 will become a new blockbuster epilepsy treatment in the world, replacing the current leader Vimpat (lacosamide).
The Korean firm expects its new drug to rack up sales of at least 1 trillion won ($842 million) in the U.S. alone, and record a sales-to-profit rate of more than 50 percent.
The global epilepsy treatment market is forecast to grow by more than 6 percent annually from about $4.9 billion to some $6.1 billion in 2018, according to global market research firm Datamonitor.
By Sohn Ji-young (jys@heraldcorp.com)