Number of drugs approved by FDA in 2013 fewer than 2012, but higher in value, study finds
NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.
The report, by EP Vantage, part of EvaluatePharma, found that the total potential value of drugs that won Food and Drug Administration approval in 2013 was $18.7 billion in their fifth year. The total number of drugs approved or expected to be approved by the Food and Drug Administration this year, 34, is behind last year’s record 43, but their fifth-year sales are expected to be 14% higher.
Drugs like Biogen Idec’s multiple sclerosis treatment Tecfidera (dimethyl fumarate) and GlaxoSmithKline’s chronic obstructive pulmonary disease treatment Breo Ellipta (fluticasone furoate; vilanterol) are expected to play a significant role in the total. And if it wins FDA approval, Gilead Sciences’ hepatitis C drug sofosbuvir is also expected to contribute significantly to the total, with almost $3 billion in sales expected in the fifth year after launch, according to EP Vantage.
J&J, Pharmacyclics add Diplomat to limited distribution network for Imbruvica
FLINT, Mich. — Diplomat has joined the limited distribution network for a rare form of blood cancer drug marketed by Johnson & Johnson and Pharmacyclics.
The specialty pharmacy said Thursday that J&J subsidiary Janssen Biotech and Pharmacyclics had added it to the limited distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma.
"We are pleased to partner with Pharmacyclics and Janssen Biotech Inc. as a specialty pharmacy provider of Imbruvica," Diplomat president Gary Kadlec said. "Diplomat has proven expertise in handling limited distribution drugs and an industry-wide reputation for comprehensive patient care outreach that improves patient compliance, adherence and outcomes."
New HIV treatment guidelines call for more vaccinations and chronic disease testing, treatment
ARLINGTON, Va. — Antiretroviral drugs have allowed people with HIV to live normal life spans, but because of this, they also are susceptible to many new health complications, according to care guidelines released Thursday by the Infectious Diseases Society of America.
The IDSA’s HIV Medicine Association said that people with HIV have an increased risk for such common health conditions as high cholesterol and triglycerides, which can result from the infection itself, antiretroviral drug treatment or traditional risk factors like smoking and unhealthy diets. The longer lifespans of HIV patients, with an estimated 80% of patients having the virus under control, mean doctors should be more vigilant, according to the group.
"This means that HIV specialists need to provide the full spectrum of primary care to these patients, and primary care physicians need a better grasp of the impact HIV care has on routine health care," lead author of the guidelines and New York University researcher Judith Aberg said. "Doctors need to tell their HIV-infected patients, ‘Your HIV disease is controlled, and we need to think about the rest of you.’ As with primary care in general, it’s about prevention."
In particular, the guidelines include new recommendations for screening for diabetes, osteoporosis, colon cancer and sexually transmitted diseases, as well as vaccinations against pneumococcal infection, influenza, varicella and hepatitis A and B. They also include information outlining interactions between specific antiretrovirals and cholesterol-lowering statins.