FDA Advisory Committee Briefing hits Bayer’s Xarelto® badly.

By Xavier Tello

xareltoOne of the most desired markets of the pharmaceutical business has been the clotting-prevention.

Ever since the first use of systemic heparin and the late surging of the low molecular weight heparins (LMWH) such as Lovenox® (enoxaparin), Fraxiparine® (nadroparin) and Arixtra® (fondaparinux); the Holly Grial has been the actual finding of an oral compound which could bring (or surpass) the benefits of them.

Xarelto® (rivaroxaban) was developed by Bayer Health Care and obtained Canadian and European marketing authorization by September 2008; and would be marketed in the US by Johnson & Johnson.

After evaluation, as part of the regulatory proceedings in the US, an FDA Advisory Committee Brieffing has issued non-favorable conclusions to Xarelto’s review. (Actually the official publishing will be tomorrow, March 19th)

As part of the conclusions, the FDA warns about a significant increase in the number of bleeding cases when compared to the so-called “standard treatment” (Lovenox®).

FDA Xarelto

From the Cardiovascular and Renal Drugs Advisory Committee; March 19, 2009

Furthermore, in a non-conclusive appreciation, the FDA comments that there could be also some liver damage evidence that could emerge when further investigation is conducted.

Get a copy of the March 19, 2009 FDA Cardiovascular and Renal Drugs Advisory Committee complete Briefing Document HERE.

The notice was seriously read by the markets, as Bayer lost 10% of share price in what Bloomberg mentions as the worst down in six years.



Source: Bloomberg

It is clear that in the last 15 years, the LMWH market has been under the hegemony of Lovenox®. At some point a competitor of Sanofi’s Fraxiparine®, it is now the star of the crown and the most powerful product of today’s sanofi-aventis’ portfolio.

The knee or hip surgical replacement, as well as the prophylaxis of the Deep Venous Thrombosis (DVT) and Pulmonary Thromboembolism market; is one of the most desirables in the business.

Annalists had considered sales up to $1.6 Bn USD by 2013. However, a 10% lost in value has been considered “an exaggeration” according to Bloomberg’s report.

It is to early perhaps, to predict the final outcome of the FDA’s opinion. At this point the only certainty is that there’s not enough long-term data as supporting evidence of a robust safety profile for Xarelto®.

Everybody knows that in the post-Vioxx FDA-culture, every submission and every dossier should (an will) be carefully studied.

The next months will be crucial for the future of Xarelto® and –as evidenced in the market reaction- for Bayer.

UPDATE: Today (19th), outside advisors to the FDA have voted 15-2 to support Xarelto® in short term use, as evidence of potential bennefits that clearly surpass the risks mentioned earlier by the Advisory Committee Meeting.

This entry was posted in Alta Dirección, Mercadotecnia, Salud, Ventas and tagged , , , , , , , , , , , , , , , , , , , . Bookmark the permalink.

Leave a Reply