Pfizer PFE announced that it is voluntarily withdrawing all lots of its sickle-cell disease (SCD) medication Oxbryta (voxelotor) from all markets where the drug is approved.

Why PFE is Withdrawing the Drug All of a Sudden?

This decision is based on the totality of clinical data, which shows that the benefit of the drug no longer outweighs the risks associated with its use. Per management, the data reflected an imbalance in vaso-occlusive crises (a common and painful complication of SCD) and fatal events that required further assessment.

Pfizer also notified regulatory authorities of these findings and its decision to withdraw the drug from the market. The company also decided to discontinue all clinical studies and access programs related to Oxbryta.

This withdrawal decision comes a couple of months after the EMA started a review of the drug. The agency initiated this review after data from two clinical studies evaluating Oxbryta showed a higher-than-expected number of deaths.

Oxbryta was added to Pfizer’s portfolio following its acquisition of Global Blood Therapeutics in 2022 for nearly $5.4 billion. The drug was initially approved by the FDA in 2019 under the accelerated pathway for use in SCD patients aged 12 years and older. The agency subsequently converted this nod to full approval in 2021 and expanded its use in patients as young as four years. The SCD drug is currently approved in more than 35 countries for SCD, including Europe.

PFE Stock Performance

Year to date, Pfizer’s shares have risen 0.4% compared with the industry’s 22.5% rise.

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Financial Impact of Oxbryta Withdrawal on Pfizer

Per management, the drug’s withdrawal is not expected to impact its financial guidance for 2024. Sales of the medication have been modest compared with other drugs in Pfizer’s portfolio. During the first half of 2024, Pfizer generated $176 million from Oxbryta sales, up 19% year over year.

Management previously raised its guidance for the year when it reported second-quarter 2024 results in July. Pfizer expects total revenues in the range of $59.5-$62.5 billion versus the prior expectation of $58.5-$61.5 billion.

Adjusted earnings are expected in the range of $2.45-$2.65 versus the prior expectation of $2.15-$2.35 per share. This range includes the expected impact of 40 cents dilution from the Seagen acquisition mainly due to the costs of financing the transaction.

PFE Zacks Rank

Pfizer currently carries a Zacks Rank #2 (Buy).

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