Novartis, Pfizer withdraw drug applications in Europe
- Pfizer and Novartis both withdrew drug applications earlier this month with the European Medicines Agency's committee in charge of reviewing and recommending approval for therapies for human use, according to a Dec. 14 release from the regulatory agency.
- Novartis pulled back on canakinumab after the Committee for Medicinal Products for Human Use raised serious concerns in its review, including questions that the Swiss drugmaker conceded it could not address within the review's timeframe. A company spokesperson told BioPharma Dive canakinumab is also being pulled from reviews in Switzerland, Australia and Canada.
- Pfizer withdrew Fyzoclad, a biosimilar of AbbVie's Humira, from consideration for a limited label due to "a change in Pfizer's strategy," according to a company letter sent to the committee on Dec. 5. An application for the full label remains under review.
Novartis has encountered difficulty in getting canakinumab, the active ingredient in Ilaris, past regulators for broader indications. In October, U.S. regulators rejected the drug as a treatment for cardiovascular risk reduction. The pharma seems to have had no better luck in Europe.
Canakinumab got the FDA's OK in 2009 and the European Commission's approval in 2009 for certain rare auto-inflammatory disorders, but Novartis was eyeing a broader label for the monoclonal antibody, particularly one to help people who have already had a heart attack avoid major cardiovascular events, such as another heart attack or a stroke.
Novartis banked on a long-term cardiovascular study as its proof, which studied more than 10,000 participants after three years of treatment. Last year, the pharma rolled out the results, showing canakinumab beat placebo. Sell-side analysts dreamed it could turn canakinumab into a blockbuster.
That hasn't panned out, however. Regulators raised concerns about the study and its outcomes, and the Swiss pharma could not address them in the approval timeframe.
The CHMP had "remaining concerns" when Novartis formally withdrew its application on Dec. 4., and called the data "not robust enough to clearly demonstrate" its efficacy in all patients who have had a heart attack. The committee's provisional opinion at the time was the "modest" benefits did not outweigh increased risk of serious infections, according to a document from the regulator.
A Novartis spokesperson said canakinumab will continue to be studied in other disease areas.
Meanwhile, Pfizer's reasons for withdrawing were much less clear, with its letter only stating a change in strategy. It did clarify it's reasons were not about efficacy or safety of the Humira (adalimumab) biosimilar.
The committee said it was still evaluating initial documentation of the application when it was withdrawn.
The first copycats of the world's top-selling drug hit the European market in October. Stronger patent protections in the U.S. have allowed AbbVie to line up settlements with multiple drugmakers for 2023 entry of copycats.
Pfizer became the seventh pharma to reach such a deal with AbbVie, which was announced a few days before the pharma withdrew the limited label application in Europe. The settlement allowed Pfizer to launch in Europe once it received a regulatory OK.
A Pfizer spokesperson said in an email to BioPharma Dive the full label application remains under review, and the company cannot comment further.
Editor's Note: This article was updated to reflect comments from a Pfizer spokesperson, including the fact that a biosimilar application with Humira's full label is still under review in Europe.
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