Antares Pharma Inc (NASDAQ:ATRS)’s Otrexup, up for FDA approval
Antares Pharma Inc (NASDAQ:ATRS) has a 14 October 2013 PDUFA date and this decision will be for the Otrexup drug. This is used in the treatment of RA or Rheumatoid Arthritis, Psoriasis and poly-articular-course juvenile RA. Otrexup has been designed by ATRS and it permits the subcutaneous administration of MTX. The latter has been used in the treatment of these indications for a very long time now..
Patients are able to self-inject this device and the company is of the opinion that the drug is a great improvement over all the treatments that are currently available. ATRS claims that this system will permit patients to stay on MTX for a longer period of time. This will lead to a significant cost reduction for RA treatment. This is because MTX is cheaper in comparison to other expensive biologics. The company believes that the use of Otrexup will also increase patient compliance as it is a self-injectible drug.
Currently, Antares Pharma Inc (NASDAQ:ATRS) has some drugs on the market but they are all via partnerships. This decision is critical for the company in that it will help ATRS generate a significant amount of revenue. If it receives the FDA not, Otrexup will be Antares’ first independently-launched drug.
For all investors who are interested in pharma stocks, an FDA approval can be a make or break situation. Thankfully, it is possible to get a tentative idea about when the FDA will make their decision. The PDUFA date of a drug is imposed by the Food Drug Administration. Though these decisions can at times, prove to be very beneficial to investors in pharmaceutical companies, they can also be potentially risky. It is advisable to buy a stock several months prior to the PDUFA date and then sell it just before the expected date. That is probably the one way to avoid risks relate to rejection or delay of FDA decision.