The FDA delayed a decision on Daiichi Sankyo's acute myeloid leukemia drug quizartinib. Meanwhile, the company's star cancer drug Enhertu tripled sales and reached blockbuster status during Daiichi's 2022 fiscal year. Merck and Glenmark settled with plaintiffs who accused them of illegal conduct in a pay-for-delay lawsuit. And more.
After an FDA rejection in 2019, Daiichi Sankyo’s FLT3 inhibitor quizartinib—approved in Japan under the brand name Vanflyta—has hit another regulatory setback. The agency has delayed its decision on the acute myeloid leukemia drug by three months to July. This time, the issue isn’t about the drug’s data, but rather that the FDA needs more time to review proposed updates to a safety monitoring program.
Daiichi’s AstraZeneca-partnered Enhertu delivered 208 billion Japanese yen ($1.6 billion) in sales during the company's fiscal year 2022, good for about 218% growth. But the drug’s U.S. haul plateaued at 44.8 billion yen in the most recent quarter, compared with 44.5 billion yen the prior quarter, suggesting its groundbreaking HER2-low indication may take additional time to ramp up. For the next fiscal year, Daiichi predicts Enhertu could reach 320 billion yen.
Merck and Glenmark have reached settlement deals with drug purchasers, payers and pharmacies in a pay-for-delay lawsuit around the old cholesterol med Zetia. The plaintiffs argued that Merck paid Glenmark some $800 million to delay the launch of the Indian company’s generic version of Zetia for nearly five years. In filings to India's stock exchange, Glenmark denied wrongdoing.
The Serum Institute of India is taking another $150 million stake in Biocon Biologics, the biosimilar business of Biocon. The new investment adds to the $150 million the Serum Institute promised in September. Under the new deal, Biocon gets access to 100 million doses of vaccines annually plus distribution rights to Serum’s vaccine portfolio.
Sun Pharma has temporarily stopped shipping drugs from its Mohali facility in India to the U.S. The FDA previously found shortfalls at the site during an August 2022 inspection. The visit led to a six-observation Form 483 filing from the FDA. Sun said it’s "taking required corrective steps."
The World Health Organization’s Pan American Health Organization (PAHO) has started early pricing negotiations with Takeda on its dengue vaccine Qdenga, PAHO’s director Jarbas Barbosa, Ph.D., said. He suggested the price could be “more affordable” if large countries such as Brazil, Mexico, Colombia and Argentina join a purchasing alliance.
SK Life Science has rolled out a new campaign to attract general neurologists’ attention to its anti-seizure treatment Xcopri. For the campaign, SK sought to demonstrate that a 50% decline in seizures is unacceptable when treating epilepsy.