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Novartis wins early US approval for major new heart drug
Novartis AG on Tuesday won U.S. approval for its keenly awaited new heart failure drug Entresto earlier than expected, boosting hopes for a medicine tipped by analysts to reap billions of dollars in annual sales.
The Swiss drugmaker had previously said U.S. approval was likely in August.
The U.S. Food and Drug Administration said in a statement that the drug had been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure, and could help patients live longer and enjoy more active lives. (1.usa.gov/1Uxv4Dv)
Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. As a result, it is expected to be one of the biggest new drug launches of 2015.
Consensus forecasts from industry analysts point to annual sales of $4.4 billion by 2020, according to Thomson Reuters Cortellis.
Novartis is looking to Entresto to help revive its fortunes in heart medicine as the blood pressure pill Diovan - a major source of the company's profits in the past - faces competition from generics.
The drug will be priced at $12.50 a day at the wholesale level, which Novartis said was in line with other new cardiovascular treatments.
Entresto will be competing with other very cheap - though less effective - pills and Novartis has warned initial uptake may be slow.
David Epstein, the company's head of pharmaceuticals, told Reuters last week he was talking to healthcare customers about a system under which they would get the drug at a discount, but then pay Novartis more if, as expected, it successfully reduces the need for costly hospital visits.
The issue of drug pricing has come to a head recently, thanks to the launch of extremely expensive new medicines for cancer and Hepatitis C, which are straining healthcare systems and adding to co-payment costs for patients.
Heart failure affects about 5.1 million people in the United States, about half of whom have the reduced ejection fraction form for which Entresto has proven suitable, where the heart muscle does not contract effectively.
Possible side effects with Entresto include low blood pressure, high blood potassium levels and poor kidney function.
Entresto is a two-in-one pill, taken twice a day, combining Diovan's active ingredient valsartan and another class of drug called a neprilysin inhibitor.
http://www.foxnews.com/health/2015/07/08/novartis-wins-early-us-approval-for-major-new-heart-drug/
The Swiss drugmaker had previously said U.S. approval was likely in August.
The U.S. Food and Drug Administration said in a statement that the drug had been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure, and could help patients live longer and enjoy more active lives. (1.usa.gov/1Uxv4Dv)
Entresto, also known as LCZ696, is the first new drug in decades for helping patients whose lives are in danger because their hearts cannot pump blood efficiently. As a result, it is expected to be one of the biggest new drug launches of 2015.
Consensus forecasts from industry analysts point to annual sales of $4.4 billion by 2020, according to Thomson Reuters Cortellis.
Novartis is looking to Entresto to help revive its fortunes in heart medicine as the blood pressure pill Diovan - a major source of the company's profits in the past - faces competition from generics.
The drug will be priced at $12.50 a day at the wholesale level, which Novartis said was in line with other new cardiovascular treatments.
Entresto will be competing with other very cheap - though less effective - pills and Novartis has warned initial uptake may be slow.
David Epstein, the company's head of pharmaceuticals, told Reuters last week he was talking to healthcare customers about a system under which they would get the drug at a discount, but then pay Novartis more if, as expected, it successfully reduces the need for costly hospital visits.
The issue of drug pricing has come to a head recently, thanks to the launch of extremely expensive new medicines for cancer and Hepatitis C, which are straining healthcare systems and adding to co-payment costs for patients.
Heart failure affects about 5.1 million people in the United States, about half of whom have the reduced ejection fraction form for which Entresto has proven suitable, where the heart muscle does not contract effectively.
Possible side effects with Entresto include low blood pressure, high blood potassium levels and poor kidney function.
Entresto is a two-in-one pill, taken twice a day, combining Diovan's active ingredient valsartan and another class of drug called a neprilysin inhibitor.
http://www.foxnews.com/health/2015/07/08/novartis-wins-early-us-approval-for-major-new-heart-drug/
Insurance companies make deals with the drug makers for what they'll charge those on their plans. Yes, this would be a second line medication to see if the generic drugs that are indicated for the same condition will work for a patient. We ALL must have insurance these days with Obamacare--- so, I am not sure it true that a 375 dollar medication a month (at full price without the insurance deal) would not be covered as a second line agent.
The issue with drug companies is what they need to continue to develop medications. Their employees make money like most professionals in other industries, CEO's make the same kind of bonuses, etc. as other industries do--- but a HUGE bulk of the profit of a drug is rolled into research and development to continue to be a company into the future.
Now advertising to the consumer? That to me can be fishy. So random people come in asking for this or that even if they don't have the condition. Extending patents way beyond what other patents would be extended just to protect profit, unethical.
But charging a high price for a drug that cost a high price to develop is not unethical to me.
Just my thoughts on it. :>)
The issue with drug companies is what they need to continue to develop medications. Their employees make money like most professionals in other industries, CEO's make the same kind of bonuses, etc. as other industries do--- but a HUGE bulk of the profit of a drug is rolled into research and development to continue to be a company into the future.
Now advertising to the consumer? That to me can be fishy. So random people come in asking for this or that even if they don't have the condition. Extending patents way beyond what other patents would be extended just to protect profit, unethical.
But charging a high price for a drug that cost a high price to develop is not unethical to me.
Just my thoughts on it. :>)
The problem I see with this, and many other new drugs is the cost... do the math - this one, at $12.50/day ($375/mo) at the wholesale level, will be so expensive that many people won't be able to afford it. Medicare and many insurance companies won't cover the newer drugs or if they do, they cover them at much lower rates, because they want people to opt for the cheaper, less expensive generics. That leaves people unable to cover the high cost of the co-pays.
Additionally, at the risk of being a "wet-blanket", we've seen some other drugs make it to market, more quickly than planned, only to find out that the side effects were more deadly than the diseases the drugs were treating.
I agree that pharmaceuticals have a right to be a business and make a profit... that's what businesses do. I just wonder if they really need to make million/billion $ profits at the expense of sick people?
Additionally, at the risk of being a "wet-blanket", we've seen some other drugs make it to market, more quickly than planned, only to find out that the side effects were more deadly than the diseases the drugs were treating.
I agree that pharmaceuticals have a right to be a business and make a profit... that's what businesses do. I just wonder if they really need to make million/billion $ profits at the expense of sick people?
I have always felt that pharmaceutical companies have a right to be a business. They employ MANY. The fact that a new novel medication is on the way for heart disease is great news. I don't expect companies to not receive profit for that.
I also think it is a really interesting concept to price it initially and then have a price after it ultimately saves money in hospital stays. That would be something to see that kind of price structure--- very out of the box thinking.
Anyway, I'm happy to see novel drugs investigated and making it to market. It's gotten very hard to do these days. and if the industry does not remain profitable, it will happen less and less.
I also think it is a really interesting concept to price it initially and then have a price after it ultimately saves money in hospital stays. That would be something to see that kind of price structure--- very out of the box thinking.
Anyway, I'm happy to see novel drugs investigated and making it to market. It's gotten very hard to do these days. and if the industry does not remain profitable, it will happen less and less.
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