Saturday, April 19, 2014

FDA green lights new drug to treat people with hay fever - State Column

Hay fever is a condition that causes cold-like signs and symptoms, such as a runny nose, itchy eyes, congestion, sneezing and sinus pressure.

The U.S. Food and Drug Administration (FDA) announced its approval earlier this week of Ragwitek, a drug that treats allergic rhinitis induced by short ragweed pollen, better known as hay fever.  The drug is approved for use in adults between the ages of 18 and 65, who are presenting with or without eye inflammation.  Ragwitek is a novel drug because it is made from an allergen extract that is administered under the tongue.

According to Occupational Health & Safety Online, Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen.  Treatment should be started 12 weeks before the start of the ragweed pollen season and continued throughout the season.  Patients on Ragwitek take the tablet once daily by placing it under their tongue and letting it dissolve.  For safety reasons, the first time a patient takes Ragwitek, they should do so in a health care professional's office, so any adverse reactions can be treated immediately.

Before the FDA approved Ragwitek, it had to demonstrate safety and efficacy.  The safety of the medication was studied by evaluating 1,700 adults in clinical studies.  Patients who were taking Ragwitek during ragweed pollen season experienced a 26 percent reduction in symptoms as compared to those who received a placebo.

The Mayo Clinic describes hay fever as a condition that causes cold-like signs and symptoms, such as a runny nose, itchy eyes, congestion, sneezing and sinus pressure.  However, unlike a cold, hay fever isn't caused by a virus.  Hay fever is caused by an allergic response to outdoor or indoor allergens, such as pollen, dust mites or pet dander.  Hay fever is associated with a reduced quality of life, poor sleep, worsening asthma, sinusitis and ear infection.

Allergies and hay fever affect millions in the U.S.  The U.S. Centers for Disease Control and Prevention (CDC) reports that in the last 12 months, 17.6 million adults and 6.6 million children were diagnosed with hay fever.  As a result of allergic rhinitis, there were 11.1 million visits to doctors in which that was the primary diagnosis.

Source : http://www.statecolumn.com/2014/04/fda-green-lights-new-drug-to-treat-people-with-hay-fever/