Novartis has won the FDA approval for a new heart failure drug which it hopes will change the way heart patients are treated the world over. The Swiss drug maker is particularly elated as the approval came a few weeks earlier than their earlier estimation which was in August.
Entresto, as the drug is named has been found to show impressive results when it comes to enabling people with heart issues to lead a more active life for longer periods than was considered possible. The new drug has been found extremely effective in those cases where the heart is unable to pump enough blood on its own.
The FDA stated Entresto does have some side effects though, prime among which is its tendency to lower blood pressure, besides increasing potassium content of blood. Entresto can also have an adverse effect on the functioning of the kidney as well.
Also, the FDA stated patients treated with Entresto also run the risk of angioedema, a condition described in MedlinePlus as a swelling that is "under the skin instead of on the surface." This is particularly applicable to the African-American community that has been found to be more susceptible to angioedema.
Entresto is not recommended for patients simultaneously taking an ACE inhibitor as this could increase risks of angioedema. However, the FDA is impressed with the way Entresto has proven effective in helping reduce deaths due to cardiovascular failure while also requiring patients to have less visits to the hospital, thereby helping curb medical expenses on part of the patients.
There has also been some complaints from patients having increased risks of dementia if treated with Entresto although Novartis chose to allay such fears claiming they are yet to come across any evidence directly linking the two.
As for its cost, Novartis stated the wholesale price of Entresto will be $12.50 a day, Reuters reported. The Swiss drug maker is hoping to generate revenues worth billions of dollars from sale of Entresto worldwide but has stated it is geared for slow uptake of the drug during the initial stages.