A lawsuit was filed on behalf of investors in AbbVie Inc. (NYSE:ABBV) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 04/18/2022 -- An investor, who purchased shares of AbbVie Inc. (NYSE: ABBV), filed a lawsuit over alleged violations of Federal Securities Laws by AbbVie Inc.
Investors who purchased shares of AbbVie Inc. (NYSE: ABBV) have certain options and for certain investors are short and strict deadlines running. Deadline: JUNE 6, 2022. NYSE: ABBV investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
Rinvoq is an anti-inflammatory drug manufactured by AbbVie Inc. and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes.
Rinvoq was initially approved in the United States to treat only moderate to severe RA.
However, the plaintiff says that AbbVie Inc. was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases and that Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc.
Xeljanz was approved in 2012 for the treatment of RA. When the FDA approved Xeljanz, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects.
Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events.
The plaintiff says that notwithstanding the similarities between Rinvoq and Xeljanz, between April 30, 2021, and August 31, 2021, the Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.
However, the investors claims, that investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz.
Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns.
On December 3, 2021, AbbVie Inc. announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed.
On January 11, 2022, AbbVie Inc. admitted that these changes to Rinvoq's label would negatively impact sales, forcing AbbVie Inc. to reduce its long-term guidance for Rinvoq's sales in 2025.
The plaintiff claims that between April 30, 2021, and August 31, 2021, the Defendants misrepresented and/or failed to disclose that safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors, that as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq, and that therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.
Those who purchased shares of AbbVie Inc. (NYSE: ABBV) have certain options and should contact the Shareholders Foundation.
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