The Food and Drug USA (FDA) approved bedaquiline development as new drugs to treat tuberculosis (TB). Bedaquiline is the only new TB drugs developed in over 50 years.
Resistance to TB drugs has become one of global health issues because every year there are nearly 500,000 new TB cases, with 150,000 deaths per year. TB treatment available today involves therapy for 2 years using many combinations of drugs that could potentially lead to resistance and serious side effects such as psychiatric disorders and hearing, with percentages around 65 percent recovery.
“This is encouraging news, that after more than 50 years there is finally an effort to develop new drugs to combat TB and will also be working more” refined “for patients with resistant TB drugs currently used. This drug can help the fight against TB mortality due to drug resistance, and improve the quality of life of patients who currently do not only have to undergo a series of complex treatment nan very long (2 years), but also suffered from a variety of other side effects. These new drugs have to be produced at a price that is affordable for developing countries where the majority of TB patients live. “Explains Dr. Grania Brigden, TB Program Access Campaign Advisor Doctors Without Borders (MSF) in a press release submitted to Kompas.com, Wednesday (19/09/2012).
Janssen R & D, LLC, a subsidiary of Johnson & Johnson, has been appointed to handle the application of FDA new drug development bedaquilin. Registered with the code of TMC207, the drug is expected to enhance concerted effort treatment of lung diseases and problems of TB drug resistance among adults, as part of combination therapy. Bedaquiline will be developed for people with TB who have problems TB drug resistance. FDA final approval to bedaquiline is expected to be achieved within the next 6 months.
Efforts to develop new TB drugs over a period of more than 50 years is also minimal, with only rely on two anti-resistance is still under investigation. Bedaquilin, one of which, formerly known as TMC-207, have been proposed by the pharmaceutical company Janssen / Johnson & Johnson to the FDA, as well as delaminid (formerly known as OPC-67 683), which was entered by a Japanese pharmaceutical companies Otsuka to the European Medicines Agency for the approved.
Good news it still requires a lot of research manyangkut ways to combine into current treatment regimens is to prevent drug resistance TB. Bedaquiline not be able to cure tuberculosis, requiring a mixture or “cocktail” of several other drugs that are currently being used to eradicate the mycobacterium tuberculosis.
FDA reviewing regularly give priority to essential drugs for diseases that are not yet available treatment options or are still very minimal. Priority review helpful offer treatment options and medications alternatif.Bedaquiline a kind diarylquinoline discovered by scientists at Janssen company.
Giving priority review by the U.S. Food and Drug USA is a recognition of the lack of results of treatment of TB medication regime that exists today, which has grown more complicated since the advent of many cases of TB drug resistance. So far, not yet certain extent bedaquilin efficacy in an effort to strengthen and improve TB drug regimens used today. Although the role of bedaquilin been identified, research is needed to ascertain how best to use these drugs to prevent the emergence of cases of tuberculosis drug resistance in the treatment of infectious diseases.