Only 4 innovative drugs, namely, MOXIFLOXACIN, CORLANOR, APTENSIO XR and KYBELLA were approved by FDA in April 2015 (Fig. 1), wherein, Corlanor and KYBELLA were approved for the first time in relevant drug fields, with huge market potential. The following is the introduction to those drugs in detail.
Fig. 1: Innovative drugs approved by FDA in April 2015
MOXIFLOXACIN
The new drug application of MOXIFLOXACIN (see Fig. 2 for the structural formula) under Fresenius Kabi was approved by FDA on April 3, 2015, which is to be used for specific infected persons susceptible to bacteria of over 18 years old.
Fig. 2: Molecular structural formula of MOXIFLOXACIN
MOXIFLOXACIN (Fig. 2) belongs to the new artificially synthesized quinolone antibacterial, and possesses merits such as wide antibacterial spectrum, strong antibacterial ability, effectiveness on common drug-resistance bacteria, not easily producing drug resistance and long half-life. Such approval was mainly specific to 6 indications of Moxifloxacin injection, including: acute bacterial rhinosinusitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and skin structure infection, complicated skin and skin structure infection, and complicated intra-abdominal infection.
As mentioned by researchers: different from other antibacterials, MOXIFLOXACIN belongs to quinolone antibacterial which targets bacterial DNA, interferes with DNA gyrase function to make bacterial DNA occur with irreversible damage, thus stopping the bacterial cell division. Furthermore, such type of drug possesses a wide antibacterial spectrum and can be used for treating the respiratory tract infection, gastrointestinal infection and joint and urinary system infection, and soft tissue infection caused by susceptible pathogens. And certainly, the biggest characteristic of such antibacterial is that it has no impact on the plasmid conduction drug resistance and rare cross drug resistance to other types of antibacterial. Therefore, MOXIFLOXACIN antibacterial is hard to be replaced by other drugs.
CORLANOR
As announced by Amgen, based on the clinical research data submitted by it with participation of 6500 patients with heart disease, the ivabradine developed by Amgen for treating heart disease was approved by FDA on April 15, 2015, which will be launched in the market under the trade name of Corlanor. It is the first new drug approval for heart disease in the world to reduce heart rate and hospitalization rate. The cardiovascular field has always of strategic importance for the pharmaceutical giants, and the approval of Corlanor further consolidates Amgen's leading position in such field.
Amgen spent USD 50 million on purchasing ivabradine from Servier. Amgen owns the exclusive sales right in the U.S. market according to the agreement between both parties. Dr. Norman Stockbridge, director of the Division of Cardiovascular of Amgen pointed out that: heart disease is one of the leading causes threatening the health of adults; Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class, which helps much in improving the quality of life of patients with heart disease and is good news to them.
However, it is worth mentioning that Corlanor was launched in the market, but according to a 3-month clinical research concerning coronary artery disease conducted by Amgen, the heart rate of patients was averagely reduced 10 beats per minute, but the mortality of such patients with heart disease was not obviously improved, as indicated by an insider.
KYBELLA
The first "double chin" lipodissolve injection-Kybella under KYTHERA BIOPHARMA INC was approved by FDA at the end of April, for treating adult patients with moderate and severe "double chine", which is currently the only non-surgical treatment for double chin and will provide a high-quality new treatment choice for "double chin" patients.
As a kind of man-made deoxycholic acid, Kybella can dissolve fat and belongs to a kind of substance naturally existing in human body. As shown by the clinical trial, compared with placebo, Kybella can effectively eliminate submental fat and improve the overall appearance of face. Patients can obtain satisfactory result by only 2-4 times of injection.
According to statistics, there are as many as 70% persons in some countries and regions such as the U.S. troubled by "double chin"; the expenditure in plastic and aesthetic surgery of American people alone is as high as USD 12 billion per year. The market potential of Kybella, as the first non-surgical treatment for "double chin", is very considerable.
Summary: FDA also approved APTENSIO XR under RHODES PHARMS in April besides the above three star drugs, wherein, Corlanor is the world's first heart disease drug that can reduce the heart rate, and Kybella is currently the only non-surgical treatment for double chin, both achieving a historic breakthrough in the approval of corresponding disease treatment field.
