New Drug Approvals - The Month That Was

(RTTNews) - The bench to bedside journey of drugs is no easy task. Some drug candidates never complete the journey while many make it to the finish line only after undergoing numerous obstacles.

Let us take a look at the new drugs that passed muster with the FDA in April.

Corlanor - for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well, and to reduce hospitalization from worsening heart failure was approved by the FDA on April 15, 2015.

The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.

Amgen Inc. (AMGN) gained U.S. rights to Corlanor from Les Laboratoires Servier through a product collaboration that was signed between the two companies in 2013.

Corlanor works to slow the heart rate by inhibiting the If current ("funny" current) in the sinoatrial node, the natural pacemaker of the heart. This is the first new chronic heart failure medicine approved in the U.S. in nearly a decade.

The most common side effects of Corlanor as observed in clinical trial participants are too much slowing of the heart rate (bradycardia), high blood pressure (hypertension), atrial fibrillation, and temporary vision disturbance (flashes of light).

Sold under the brand name Procoralan by Servier, the drug was approved by the European Medicines Agency in 2005 for the symptomatic treatment of stable angina and in 2012 for chronic heart failure in patients with elevated heart rates.

Novartis is also developing a drug to improve important heart failure related outcomes such as cardiovascular mortality, hospitalization and quality of life - LCZ696. The NDA for LCZ696 is under priority review by the FDA, with a decision slated for August of this year.

Kybella - was approved as a treatment for adults with moderate-to-severe fat below the chin, known as submental fat, on April 29, 2015.

Manufactured by Kythera Biopharmaceuticals Inc. (KYTH), Kybella is administered as an injection into the fat tissue in the submental area to destroy the fat cells. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.

Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.

Swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area are some of the common side effects of Kybella while a serious side affect associated with its use is the nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing.

Kybella, which is the first and only approved non-surgical treatment for reduction of submental fullnes, is expected to generate over $500 million in annual sales.

Since Kybella should only be administered by a trained healthcare professional, Kythera will initiate physician training programs in late summer. Physicians will be able to purchase Kybella and treat their patients after they have been trained.

Want to know which drugs are facing regulatory decision this month?

Please visit our FDA Calendar page.