The biopharmaceutical company, Amgen Inc.(AMGN, Financial), has been bringing several drugs into the U.S. market which have helped to improve its sales over the years. On similar lines and with the interest of serving the community, Amgen has filed for its cholesterol fighting drug named Repatha with the U.S. FDA. This drug is expected to be a revolutionary achievement for the pharmaceutical firm, if it receives the required approval from the FDA which is expected to be released by August 27. This drug will compete with its immediate rival Sanofi SA (SNY, Financial) that has also filed for approval of a similar drug catering to patients having high levels of cholesterol which is not manageable by administration of statins. Let’s find out how this new drug could bring a turnaround in Amgen’s future sales and how it works to provide better aid to high-cholesterol suffering patients. Also, let’s take a look at what are the chances of Repatha getting approved in the U.S. this year.
The EU approval adds an accolade
Repatha has recently won approval for the revolutionary drug from the European Union in terms of getting positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This is usually followed by the endorsement from the European Commission within the next few months. Such a positive response from the European Union marks the expected victory of Amgen to be one of the first among its rivals to market this much-awaited cholesterol fighter.
The benefits from this new drug
Repatha is used to reduce the level of serum LDL in the blood in heart patients who suffer from cardiovascular attacks due to high levels of LDL, despite the maximum intake of statins or those who cannot take statins.
The drug is being referred to as PCSK9 protein inhibitors, as the new class of cholesterol-fighting antibodies would block the activity of the PCSK9 gene in the body, thereby lowering the proportion of low density lipoprotein cholesterol in the human blood. This in turn would aid in reducing the accumulation of fat in blood vessels, thus preventing the risk of heart attacks to a considerable extent in patients prone to cardiovascular diseases.
It is being believed that this drug world serve better patients who cannot be treated with statins such as Lipitor of Pfizer. These PCSK9 inhibitors have been studied thoroughly during clinical trials and have been found to reduce bad cholesterol levels by as much as 50%, though their effect on serious heart issues is still to be seen. Amgen’s rival, Sanofi, had revealed in 2013 that around 21 million people globally fail to reduce their LDL levels through use of statins. Hence, this drug can bring in a sea change in the treatment of cardiovascular attacks if it wins approval from the FDA in the next few months.
Benefitting Amgen in the long run
As statins are not always effective in treatment for lowering LDL levels, the market for PCSK9 inhibitors seems to growing in the past few years with Sanofi also applying to the FDA for a similar drug which is pending approval. Pfizer (PFE, Financial) is also experimenting on the same lines though it has still not filed any drug for regulatory approval lately.
It has been estimated that such PCSK9 inhibiting drugs would carry a price tag ranging from $7000-$12,000 per patient for a year’s worth of dosage. Analysts have opined that such highly effective drugs, though available in the market with a huge price tag, could help in fetching annual sales worth more than $12 billion for the companies bringing in such expensive drugs in the near future.
Last word
With this revolutionary drug, Amgen can create a niche for itself in the cardiovascular space and would be able to compete better with its main rival Sanofi, which will have a similar drug in the market by then. While a drug price war is surely expected between these two rivals in the coming years, all eyes are now waiting to find out if Repatha wins the final approval from the FDA after receiving the recommendation from the EMA. Let’s stay tuned for the news of the final approval.
