Merck to seek FDA approval for new weight loss and cholesterol drugs

Merck & Co. will apply for the FDA approval of its new weight loss and cholesterol drugs in 2008.

Merck is all set to expand its business by introducing two new drugs for weight loss and cholesterol treatment. These two problems are the potential causes of some of the most prevalent diseases with high cholesterol levels and obesity causing cardiac disorders, hypertension and other problems.

The cholesterol drug to be applied for the approval will contain Zocor which was very successful earlier. Its patent expired in 2006. The main reason for the cholesterol level rise in the body is the increase in the amounts of the Low Density Lipoproteins (LDLs) and triglycerides. The drug increases the amount of High Density Lipoproteins (HDLs) which are beneficial for the body as the levels of LDLs get reduced.

Merck is also in the process of another cholesterol reducing drug called Anacetrapib, which is still in the experimental stage. The additional benefit of this drug is that it does not affect the blood pressure of the patient while reducing the levels of LDLs and increasing the levels of HDLs.

The weight loss drug called Taranabant which will also be sent for approval in 2008 is similar to the drug “Rimonabant” manufactured by Merck’s biggest competitor Sanofi-Aventis. It is worth mentioning that the FDA approval of Rimonabant was withdrawn as there were reports of increasing suicidal thoughts in the patients taking this drug.

Dr. Peter Kim, president of Merck Research Laboratories, said that the early stage tests of Taranabant did not include the patients suffering from depression. The test patients did not even include those who were on anti-depressants and the ones having a history of depression. He also mentioned that some “psychiatric adverse effects” were observed in the test patients, the intensity varying with the amount of drug dosage taken.

He mentioned that current level of tests will take proper notice and record all the mental and behavioral changes in people taking the medicine. At present the patients who are taking single anti-depressant are being administered but the ones taking multi anti depression drugs will soon be included.

"We are going to be meeting or beating the FDA requirements for submission of an obesity drug," said Dr. Kim.

The company’s growth in the past few years has been exponential with the stock value rising around 44% in the current fiscal year. On Nov. 9, Merck announced a $4.85 billion settlement covering 27,000 of the lawsuits, which increased the company’s stock prices.

Merck Chief Executive Richard Clark said that company’s continuous growth is mainly due to the new launched drugs which have been really successful. These drugs include cervical cancer vaccine Gardasil and the diabetes drug Januvia. Gardasil is being viewed for the additional use of preventing vaginal and vulvar cancers.

Merck has launched seven new drugs and vaccines, including the newly-launched HIV treatment drug Isentress, which is approved for patients with drug-resistant HIV strains and is now also being considered for the patients who have not been previously treated.

Merck is also expecting the approval of two more drugs next year: Cordaptive and the injectable treatment Emend. Cordaptive is still an experimental drug for the cholesterol treatment whereas Emend is already available in the capsule form and cures nausea.

All these drugs are the recent success stories of Merck & Co. and the company also has a bright future with all the new drugs coming up. The investors and the markets are also showing faith in the company which is evident from the rising share prices of the company.