AbbVie and Janssen voluntarily withdraw Imbruvica from accelerated approvals for MCL and MZL

AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S. 

Ibrutinib is a selective Bruton’s tyrosine kinase (BTK).

The main reasons for the move relate to FDA’s request for additional studies to confirm clinical benefits that relate to the accelerated approval status granted by the FDA for MCL and MZL. Initially, FDA authorized the accelerated approval program for the two indications following the publication of positive overall response rate data in phase 2 trials. 

While the phase 3 shine study in previously untreated MCL met its primary endpoint of progression-free survival, there was an increased rate of adverse reactions when combining Imbruvica and chemotherapy  compared to the placebo-controlled arm. 

Conversely, the phase 3 SELENE study in re…

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Janssen gets positive CHMP opinion for Imbruvica for adults with untreated chronic lymphocytic leukemia

Janssen (NYSE:JNJ) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Imbruvica (ibrutinib) with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL).

In the EU, the drug is also indicated for certain patients with mantle cell lymphoma, previously treated chronic lymphocytic leukemia and Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma.

CHMP’s recent positive opinion was based on the Phase 3 GLOW and Phase 2 CAPTIVATE studies.

Janssen noted in a press release that if the new indication is approved, Imbruvica will be the first oral, once-daily, fixed-duration, combination regimen for first-line treatment of CLL.

Janssen developed the drug with Pharmacyclics LLC, an AbbVie company.

Imbruvica is a Bruton’s tyrosine kinase inhibitor. Venetoclax is an apoptosis stimulant and proto…

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AbbVie faces Senate questions related to tax practices

Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices.

In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016.

Wyden has sent a letter to AbbVie CEO Richard Gonzalez seeking information about the company’s tax practices.

In the letter, Wyden questioned why the company reported a U.S. pretax loss of $4.5 billion while an offshore pretax profit of $7.9 billion in 2020. “Despite the United States market being the source of most of AbbVie’s revenues and richest price premiums, it appears that the company has consistently reported net losses in the United States while reporting substantial foreign profits,” he wrote.

AbbVie did not immediately respond to a request for comment regarding Wyden’s investigation.

AbbVie is also the subject of a May report from the House Committee on Oversight and Reform…

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House report accuses AbbVie of price gouging

A recent report from the House Oversight and Reform Committee concluded that AbbVie (NYSE:ABBV) aggressively increased prices of popular drugs, including the bestseller Humira (adalimumab), which brought in close to $20 billion last year. Approximately $16 billion of those sales were in the U.S.

In recent years, the company also repeatedly increased the price of the small-molecule drug Imbruvica (ibrutinib), according to the report, which is the result of a two-year investigation. AbbVie jointly markets Imbruvica with Janssen (NYSE:JNJ).

An annual supply of Humira costs approximately $77,000, while a year’s worth of Imbruvica is $181,529, according to the House report. The price of the latter has increased 82% since the drug launched in 2013. Outside of the U.S., the cost of Humira has fallen in recent years.

“AbbVie pursued a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend it…

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