One of the biggest recent breakthroughs in cardiovascular medicine has been the development of a new class of cholesterol lowering drugs known as PCSK9 inhibitors. The promising new class of drugs is seeking approval as an alternative to statins for the reduction in low-density lipoprotein (LDL), or so-called bad cholesterol. Now the cholesterol drug, being developed by Regeneron and Sanofi, may be delayed after the FDA requested an investigation of possible neurocognitive side effects.
Current treatments for high LDL that cannot be controlled with dietary changes use statins, which work by reducing the liver’s production of cholesterol. There are currently a number of statins on the market, and they have been in use since the 1980’s. Regeneron’s new lipid-lowering drug, alirocumab, has been shown in clinical trials thus far to reduce cholesterol even more than a statin, with hopes of other cardiovascular benefits as well. Alirocumab could also have an entire niche in the market all to themselves, as some people are unable to tolerate the side effects of statins, which can include muscle pain or nausea. This drug represents the future of an already booming company.
Regeneron has seen the price of its stock soar over 220% in the past two years, much of it on the back of the company’s last breakthrough drug, Eylea, a medicine used in the treatment of macular degeneration related vision loss. Alirocumab could be an even bigger boon to Regeneron, as cholesterol treating medications are one of the most commonly prescribed in the nation. But with a recent statement by the FDA calling for the cholesterol drug to be investigated for possible neurocognitive side effects, Regeneron may be staring at a delay in approval as clinical trials may have to be extended. The company, along with its partner Sanofi, were hoping to have approval by the end of 2015.
The FDA request comes after the government agency became aware of the possibility of neurocognitive side effects in addition to the other possible side effects already being measured by the trials, which are similar to those associated with statins. There is no official word for why the FDA thinks neurocognitive testing may be necessary, but a possible reason for their statement is that statins have in rare cases shown to be linked to the same symptoms. While the two drug classes act on different processes in the body, they result in similar outcomes, and so incorporating neurocognitive testing into the clinical trials may be seen as a necessity to ensure a safe product on the market.
Regeneron hopes that this will not result in a delay as they hope to simply continue with their current trials with the FDA’s recommendation in mind. The news has already had an adverse impact on the companies, though, with Regeneron’s stock price taking a rather significant 8 percent dip, and Sanofi dropping 1 percent. If the investigation is shown to be nothing more than the FDA attempting to be thorough, and delays are not caused, expect this cholesterol-reducing drug to be not only available in 2015 or 2016, but widely circulated very shortly after.
By Brian Moore