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| Daewoong Pharmaceutical's botulinum toxin product, called Nabota, waits for FDA approval. / Courtesy of Daewoong Pharmaceutical |
By Jun Ji-hye
The ongoing U.S. government shutdown has left Korean drug companies hanging, including Daewoong Pharmaceutical and SK Biopharmaceuticals, as the closed Food and Drug Administration (FDA) has been unable to review and approve medicines.
Officials at Korean companies, waiting for approval or applying for new drug candidates, said Friday the U.S. government shutdown was an unexpected factor at a time when they were speeding up efforts to make inroads into global markets.
Though no delays in the approval process have been announced, the companies are keenly monitoring developments of the situation to brace for every possibility, they said.
Daewoong Pharmaceutical has been waiting for FDA approval for its botulinum toxin product, called Nabota. The firm said Aug. 30 that it received an acceptance letter from the FDA about the resubmission of the Biologic License Application.
Nabota is administered via injections to improve frown lines and arm paralysis, according to the firm.
The firm expected the approval to be issued on Feb. 2, and its product to be able to go on sale in major markets including the United States and Europe within the first half of the year.
If the U.S. government shutdown extends over a longer period of time, it could deal a blow to the firm's plan.
Industry officials believe companies can gain a foothold in enhancing their global competitiveness by entering the U.S. market as it accounts for about 40 percent of the global market.
"The government shutdown was an unexpected thing," an official from Daewoong Pharmaceutical said. "We have yet to be informed of any delays. We are not considering changing our business plans as of now as nobody knows what will happen next."
SK Biopharmaceuticals has also been waiting for FDA approval since November when it submitted the New Drug Application for Cenobamate, aimed at treating epilepsy.
At the time, the firm said it was set to challenge the U.S. market, the world's largest bio-pharma battlefield, with the new drug developed with its own technology.
It said its new drug would be available for sale in the first half of 2020 once it receives FDA approval.
Industry watchers said there does not seem to be a problem as the firm submitted the application before the government shutdown began, but the possibility for delay cannot be ruled out.
"There are many predictions as the FDA's work speed has slowed down, but we have yet to receive any official information about delay," an official from SK Biopharmaceuticals said.
California-based Aimmune Therapeutics has been directly affected by the U.S. government shutdown as the FDA notified the company it cannot begin to review the firm's Biologics License Application for AR101, a peanut allergy drug, until the lapse in appropriations end.
Aimmune filed for FDA approval of its product on Dec. 21, a day before the shutdown began.
