Drug Approvals In The US Hit Record High: Bio Tech Stocks On A Roll
Drug approvals in the United States have been a record high in 2014 compared to the last 18 years. The U.S. Food and Drug Administration gave approval to 41 novel medicines in the year that passed, which was up by 14 medicines in the previous year, according to the FDA website. That tally is matched only by the all-time high approval of 53 medicines in 1996.
Consequently, the drug enthusiasm also gave a shot in the arm to the biotech initial public offerings. The IPOs from the sector hit a record high in 2014 and the action in the drug industry lifted the Nasdaq Biotechnology Index and S&P 500 Health Care Index 34 percent and 23 percent respectively, reported Reuters.
For the U.S. drug makers, this is a new awakening after the losss of many patents on blockbuster products. Now drug makers are testing their ability to bring new medicines of enhanced productivity. In Europe, the European Medicines Agency, along with generic drugs, recommended 82 new medicines in 2014 that is up from 79 in 2013 and 57 in 2012.
What is significant about the new medicines is that these innovative drugs are commanding premium prices and adding more value to the investors. But high prices are of concern to insurers and governments, who are trying to push back against the sky-high cost of some modern therapies. Nearly 40 percent of new drugs approved in the United States in 2014 was meant for rare diseases, underscoring the industry's new focus on specialised products in which competition is limited.
Cancer Drugs
The highlights of new medicines approved in 2014 include the launch of cancer drugs boosting the body's immune cells to fight tumors and promise better, with fewer side effects. Merck & Co's Keytruda and Bristol-Myers Squibb's Opdivo can block a protein called Programmed Death receptor. They were part of the first wave of immunotherapies and have the potential to generate annual sales of more than $30 billion a year.
Among the newly approved FDA drugs in the U.S. include a weight-loss drug. Saxenda or liraglutide. This is to target adults who are obese or overweight and have at least one weight-related health condition, such as high blood pressure, type 2 diabetes or high cholesterol. The drug is made by Novo Nordisk and mandates the users to follow a low-calorie diet and regular exercise, reported Health US News. Dr. James Smith, deputy director of the division of metabolism and endocrinology products in the FDA referred to its relevance and noted that, "Obesity is a public health concern and overall well-being of patients."
Cystic Fibrosis
FDA also approved Kalydeco by Vertex Pharmaceuticals, used in cystic fibrosis treatment. The approved drug can treat different gene mutations in patients. Such complex patients make up 4 percent of CF patients in the U.S, reported Bio Flash.
(The writer can be contacted at kalyandelhi@gmail.com)