FDA approves Rayos
DEERFIELD, Ill. — Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.
The drug maker said Rayos (prednisone) delayed-release tablets — in the 1-mg, 2-mg and 5-mg stregnths — were approved for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease.
"We are extremely pleased the FDA has approved Rayos for a broad range of indications, including RA and polymyalgia rheumatica," Horizon Pharma chairman, president and CEO Timothy Walbert said. "Our initial focus will be on the launch of Rayos in rheumatologic diseases, such as RA and polymyalgia rheumatica, in the fourth quarter of this year. Based on the extent of the approved indications, we will be developing a broader commercial strategy to expand the opportunity for Rayos in key IL-6 mediated diseases, including asthma and COPD."
MinuteClinic readies for BTS season, fall sports practice
WOONSOCKET, R.I. — MinuteClinic, the walk-in medical clinics inside CVS/pharmacy stores in 25 states and the District of Columbia, is gearing up for the back-to-school season by reminding parents that it is a one-stop location where students can get their required vaccinations and sports and college physicals as four states issue new immunization mandates.
"MinuteClinic practitioners are a great resource for parents who may be confused about school or sports health requirements and want to make sure their children are up to date with immunizations before the first day of school or practice," stated Paulette Thabault, MinuteClinic chief nurse practitioner officer. "All MinuteClinic locations are open seven days a week and are fully stocked with vaccines to protect against whooping cough (pertussis), hepatitis A and B, measles, tetanus, meningitis and other diseases."
Four states issue new immunization mandates
According to the CDC, the United States is on track to have the highest number of whooping cough cases since 1959. Four states — California, Illinois, Oklahoma and South Carolina — recently have changed their immunization mandates and now join other states in requiring students to obtain a Tdap booster prior to beginning middle school. States already requiring the booster include Arizona, Florida, Indiana, Kansas, Michigan, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and the District of Columbia.
Whooping cough is a highly contagious respiratory infection that affects individuals of any age, but is potentially fatal when contracted by an infant. Family members and anyone who comes in contact with young children are encouraged to get boosters regardless of legal requirements, as they often unknowingly pass along the infection.
Meningitis immunization guidelines also have changed. A new Texas law requires all first-year college students in 2012 to have a meningitis vaccination prior to beginning classes. Connecticut, Florida, Kansas, Maryland, Massachusetts, Nevada, New Jersey, Oklahoma, Pennsylvania, Virginia and the District of Columbia are among the others with meningitis vaccine requirements for incoming freshman.
Bacterial meningitis is a life-threatening disease caused by the inflammation of the membranes that cover the brain and spinal cord. According to the CDC, young adults living and going to class on crowded college or boarding school campuses and surrounded by individuals from various geographic areas are at highest risk for the disease.
Vaccinations at MinuteClinic may be covered by health insurance plans, so patients should check with their insurance provider for coverage details.
Sports and college physicals
With football, cross country, field hockey, soccer and other fall sports practices about to begin, MinuteClinic also offers sports physicals for student athletes who need preparticipation exams, often required by many states, school systems and athletic leagues. In addition, many colleges and universities require incoming freshmen to receive a physical prior to arriving on campus.
During a sports or college physical, MinuteClinic practitioners review medical history and check to see if immunizations are up to date; check vital signs and reflexes; and provide an overall assessment of physical condition to make sure young adults are not at risk for illness or injury. Practitioners also discuss sports safety measures with athletes, including the use of mouth guards, the importance of proper-fitting shoes and equipment, and tips on how to remain hydrated throughout games and practices.
Once a child is cleared for participation or admission, practitioners stamp any required forms and reference the exam results on the official patient summary. Sports physicals at MinuteClinic are $49 through Sept. 30. Coaches and athletic directors can secure group discounts for $5 off per athlete when they register their team of 12 or more at MinuteClinic.com/Discount. College physicals are $69. Sports and college physicals are not covered by insurance.
In addition, MinuteClinic practitioners administer vaccinations, conduct physicals and wellness screenings, and offer monitoring and point-of-care testing for such chronic conditions as diabetes, high cholesterol and blood pressure.
FDA panel recommends new approval for Genentech eye drug
SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.
Genentech, a subsidiary of Swiss drug maker Roche, said the FDA Dermatologic and Ophthalmic Drugs Advisory Committe’s 10 members had voted unanimously to recommend approval of Lucentis (ranibizumab) in the 0.3-mg dose for DME, while voting 8-2 to recommend approval of the 0.5-mg dose. The FDA is not required to follow advisory committee recommendations when deciding whether or not to approve a drug, but usually does. The agency is expected to make its decision on Aug. 10. Lucentis already is approved for treating wet age-related macular degeneration.
DME is an eye condition in people with diabetes that causes swelling of the retina and blurred vision, and is a major cause of vision loss and blindness in diabetics, affecting more than 560,000 people in the United States.
"The committee’s recommendation is an important step toward the goal of helping to redefine the standard of care for Americans with diabetic macular edema," Genentech chief medical officer and head of global product development Hal Barron said. "There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA’s decision."