On Wednesday, Pfizer Inc. (NYSE:PFE) said the company is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved.
Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
Pfizer's decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.
Also Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19.
The data suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment.
A vaso-occlusive crisis is a common painful complication of sickle cell anemia.
Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.
The company does not anticipate the event impacting its full-year 2024 financial guidance.
In the second quarter of 2024, Oxbryta generated sales of $92 million, up 20% year-over-year. Pfizer added Oxbryta to its portfolio via its $5.4 billion buyout of Global Blood Therapeutics in 2022.
In July, the European Medicines Agency (EMA) initiated a review of Oxbryta (voxelotor) following clinical trial data indicating a higher number of deaths in patients receiving Oxbryta compared to those on a placebo. Another trial also reported more deaths than expected overall.
One trial focused on patients with sickle cell disease who were at increased risk of stroke, while the other studied the drug's impact on leg ulcers, a common complication of the condition.
The manufacturer has now halted Oxbryta treatment in both trials, which are pending further investigation.
In November 2019, the FDA granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease.
Price Action: PFE stock is down 0.54% at $28.78 at the last check on Thursday.
- EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia.