Global Insight Perspective | |
Significance | In a step taken in past drug-safety disputes, investors in GSK have launched a class action lawsuit alleging the company made false statements on the safety of Avandia. Meanwhile, oral lung cancer drug Hycamtin will be reviewed in six months by the FDA as a result of the priority review status. |
Implications | The investors’ legal action, and the emergence of a few patient lawsuits significantly add to the furore over the safety profile of GSK’s second best-selling drug. However, the investors are likely to pleased that the FDA recognised significant differences between oral Hycamtin and existing therapies. |
Outlook | Despite GSK’s strong defence, the bad publicity and the launch of the lawsuit does not bode well for the already dwindling total share of new Avandia prescriptions. Meanwhile, GSK could add to its growing arsenal of cancer drugs if oral Hycamtin secures U.S. approval in six months time. |
Shareholder Lawsuit
Shareholders of British firm GlaxoSmithKline (GSK) have filed a lawsuit in the U.S. district court claiming the company misinformed investors about the safety of diabetes drug Avandia.
U.S. law firm Kaplan Fox & Kilsheimer LLP filed the class action suit in the U.S. District Court for the Southern District of New York, against GSK and both its chief executive Jean-Pierre Garnier and chief financial officer Julian Heslop. The law firm said it was prosecuting the company on behalf of all individuals or entities who bought GSK securities between 27 October 2006 and 21 May 2007.
The suit claims GSK did not properly divulge that it had undertaken a pooled or meta-analysis that associated Avandia with a higher risk of heart attacks in comparison to other diabetes drugs. GSK only made its meta-analysis public after prominent cardiologist Steven Nissen published his own pooled analysis last month in the New England Journal of Medicine (NEJM), which linked Avandia to heightened risk of heart attack.
The FDA received preliminary results from GSK’s analysis in September 2005, which was followed by updated findings in August 2006, according to Kaplan. The British firm made those results available on the company website. However, the lawsuit claims the findings were “never adequately disclosed to the investing public”.
An unnamed GSK spokeswoman refutes the claims and continues to uphold Avandia’s safety profile, according to TheWall Street Journal Europe. She said the company has been “transparent” when exhaustively assessing the safety and effectiveness of the drug. Furthermore, GSK has “widely” divulged the information to regulatory authorities, doctors, scientific peers and others in a variety of ways, the spokesperson added.
Quick Review for Oral Hycamtin
Meanwhile, GSK revealed that the FDA has granted priority review status to the oral version of Hycamtin (topotecan hydrochloride) for relapsed small cell lung cancer. Under the priority review status, Hycamtin will be reviewed within six months instead of the standard 10-to-12 month review period.
Outlook and Implications
The shareholder lawsuit comes as The Wall Street Journal Europe revealed that patients prescribed Avandia have also started filing their own cases against GSK after claiming the drug induced heart attacks. As expected, these suits accuse the British firm of failing to warn consumers and of omitting or misrepresenting key safety data about the diabetes drug. However, these plaintiffs may find it difficult to back up their case, as diabetes itself leads to a heightened risk of heart attacks, according to lawyers seasoned in drug safety trials.
Ever since Nissen’s article was published, GSK has launched a robust defence of Avandia, including the release of long-term studies data and the more unusual step of taking full ads in major U.S. newspapers. But since then, the FDA has asked for Avandia’s label, which already warns of a risk of heart problems, to be strengthened with a “black-box” alert. Worryingly, Avandia’s total share of new prescriptions has slumped almost two weeks into the furore.
Meanwhile, news that oral Hycamtin could reach the market faster bodes well for GSK’s growing portfolio of cancer products. The new capsule form, if approved, will allow patients to be treated at home. The priority review status has clearly recognised that this represents a significant advancement over existing therapies, including the current intravenous formulation of Hycamtin, which requires five consecutive days of therapy every three weeks.