Health & Medicine
FDA Clears New Drug Ragwitek to Treat Adults With Hay Fever
Benita Matilda
First Posted: Apr 19, 2014 06:11 AM EDT
The U.S. Food and Drug Administration regulators have cleared a new drug 'Ragwitek' to treat hay fever, with or without conjunctivitis, in adults.
The federal agency announced approval of a new drug Ragwitek to treat short ragweed pollen induced allergic rhinitis known as hay fever. Ragwitek is the first allergen extract approved to treat adults of 18 years through 65 years of age. The drug contains an extract from the short ragweed pollen (Ambrosia artemisiifolia).
The newly approved tablet is to be taken once daily and is meant to be placed under the tongue where it dissolves rapidly. The treatment can start 12 weeks before the start of ragweed pollen season and should be continued throughout the season. The regulators make it clear that the first dose should be taken under the guidance of healthcare professional as the patient needs to be under observation for nearly 30 minutes after taking the tablet for adverse reactions if any.
"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
Patients with hay fever, with or without conjunctivitis, may have a runny nose, continuous episodes of sneezing, nasal itching & congestion, itchy and watery eyes.
During the late summers and the early fall, it is hay fever season a lot of people suffer from it.
To check the safety and effectiveness of the new drug, a study was conducted on 1,700 adults. The most common adverse reaction noticed was itching in mouth and ears. The effectiveness of this drug was tested on 760 adults. The patients were randomly given Ragwitek or a placebo. The symptoms of patients were reported and also the additional medications used to treat the condition. Those who received the new drug experienced a 26 percent reduction in their symptoms and the also in the need for medication compared to those taking the placebo.
The drug carries a boxed warning cautioning users about severe allergic reactions and a few can even be life threatening.
This new drug is manufactured by Catalent Pharma Solutions Ltd, U.K.
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First Posted: Apr 19, 2014 06:11 AM EDT
The U.S. Food and Drug Administration regulators have cleared a new drug 'Ragwitek' to treat hay fever, with or without conjunctivitis, in adults.
The federal agency announced approval of a new drug Ragwitek to treat short ragweed pollen induced allergic rhinitis known as hay fever. Ragwitek is the first allergen extract approved to treat adults of 18 years through 65 years of age. The drug contains an extract from the short ragweed pollen (Ambrosia artemisiifolia).
The newly approved tablet is to be taken once daily and is meant to be placed under the tongue where it dissolves rapidly. The treatment can start 12 weeks before the start of ragweed pollen season and should be continued throughout the season. The regulators make it clear that the first dose should be taken under the guidance of healthcare professional as the patient needs to be under observation for nearly 30 minutes after taking the tablet for adverse reactions if any.
"The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the United States an alternative to allergy shots to help manage their disease," Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
Patients with hay fever, with or without conjunctivitis, may have a runny nose, continuous episodes of sneezing, nasal itching & congestion, itchy and watery eyes.
During the late summers and the early fall, it is hay fever season a lot of people suffer from it.
To check the safety and effectiveness of the new drug, a study was conducted on 1,700 adults. The most common adverse reaction noticed was itching in mouth and ears. The effectiveness of this drug was tested on 760 adults. The patients were randomly given Ragwitek or a placebo. The symptoms of patients were reported and also the additional medications used to treat the condition. Those who received the new drug experienced a 26 percent reduction in their symptoms and the also in the need for medication compared to those taking the placebo.
The drug carries a boxed warning cautioning users about severe allergic reactions and a few can even be life threatening.
This new drug is manufactured by Catalent Pharma Solutions Ltd, U.K.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone