Global Medicines Company Global Blood Therapeutics (GBT) has voluntarily withdrawn its sickle cell disease drug, voxelotor, from the market following safety concerns raised by data analysis. The company is working with healthcare professionals to develop transition plans for patients currently taking the medication.
with the urgent task of reaching patients taking the medicine, while trying to understand why it was taken off the market.issued a statement urging patients not to stop voxelotor abruptly. Instead, they should work out plans with their physicians and medical teams for weaning plans.
The US Food and Drug Administration , which first cleared voxelotor for sale in 2019, also said it has been conducting a safety review of the drug. The agency continues to examine post-marketing clinical trial data for voxelotor, the real-world registry studies, and data from the FDA Adverse Event Reporting System. At the conclusion of this review, the FDA will communicate any additional findings, if necessary, the agency said.
The FDA approved this in 1998 for use in SCD. It reduces the frequency of painful crises and acute chest syndrome and other complications of SCD that otherwise could be serious or even lethal, Pecker said."Older doctors can tell you that what they experienced with sickle cell disease in the hospitals has been completely transformed because of the high uptake of the drug," she said, adding that it made a"profound" change.
Voxelotor Sickle Cell Disease Drug Withdrawal Safety Concerns EMA FDA
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Lady Gaga & Bruno Mars’ ‘Die With a Smile’ Spends Second Week at No. 1 on Billboard Global ChartsThe song holds atop both the Global 200 and Global Excl. U.S.
Read more »
Lady Gaga & Bruno Mars’ ‘Die With a Smile’ Hits No. 1 on Billboard Global ChartsThe song ascends to the top of both the Global 200 and Global Excl. U.S.
Read more »
Thousands of demonstrators call for Turkey's new stray dogs law to be withdrawnThousands of demonstrators gathered in Istanbul on Sunday to protest a recent piece of legislation that critics say is leading to the killing of stray dogs across Turkey.
Read more »
Gilbert school board candidate withdrawn from election after death but remains on ballotManuelita Beck is a journalist with nearly two decades of experience in digital transformation, editing, and multimedia production.
Read more »
40 Million XRP Withdrawal Stuns Top Crypto ExchangeXRP whales have withdrawn 40 million XRP tokens from Bybit
Read more »
30 Million XRP Withdrawal Stuns Top Crypto ExchangeAlmost $17.6 million in XRP withdrawn from leading exchange
Read more »