Three strikes in pharma: Exploring recent drug withdrawals and clinical trial challenges

Pharmaceutical companies face a long list of regulatory challenges ranging from patent expiry to bioequivalence and international harmonization. It’s not uncommon for drug makers to withdraw or discontinue drugs after failing to meet clinical requirements or endpoints, resulting in drug withdrawals. On average, life science companies pull roughly 4,500 drugs and devices from the market, many of which are widely used. In recent years, drug companies, for instance, have pulled a growing number of products for nitrosamine contamination. While the FDA can identify safety concerns, it often falls upon the manufacturer to initiate and execute a recall.

Here, we round up three recent examples of recent drug withdrawals where pharma companies either pulled drugs from the market or gave up on developing a drug for a given indication.

Covis Pharma withdraws Makena

The Zug, Switzerland–based company withdrew Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women with a history of spontaneous preterm birth. In October 2022, FDA’s independent Obstetrics, Reproductive, and Urologic Drugs Advisory Committee voted nearly unanimously recommended pulling the drug. FDA recently yanked the approval for the drug based on the recommendation from the Center for Drug Evaluation and Research (CDER).

AbbVie and J&J withdraw Imbruvica for MCL and MZL patients

The pharmaceutical giants voluntarily withdrew IMBRUVICA (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S. as a result of requirements related to its FDA’s accelerated approval status. The withdrawal followed the results of the SHINE and SELENE phase 3 confirmatory trials, which failed to meet primary endpoints or showed increased adverse reactions compared to placebo-controlled arms.

Pharmacyclics and Janssen Biotech initially developed Imbruvica. Following AbbVie’s acquisition of Pharmacyclics, Janssen Biotech and AbbVie now collaborate in marketing the drug.

Merck and Eisai discontinue Keytruda-Lenvima combo melanoma program

Merck (NYSE:MRK) and Eisai (TYO: 4523) discontinued the melanoma program for their Keytruda-Lenvima combination after the LEAP-003 and LEAP-017 failed phase 3 trials. In particular, the combination did not show statistically significant and clinically meaningful improvements in overall survival (OS) or progression-free survival (PFS) for patients with unresectable or metastatic melanoma and colorectal cancer.

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Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development
Tagged With: clinical trials, drug development, drug withdrawals, FDA approvals, market challenges, pharmaceutical companies, regulatory hurdles
 

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