Janssen’s Stelara gets FDA nod for adolescent indication
SILVER SPRING, Md. — Janssen Biotech’s Stelara (ustekinumab) has a new indication. The Food and Drug Administration on Monday approved the drug to treat adolescents ages 12 years and older with moderate-to-severe plaque psoriasis.
According to the World Health Organization, roughly one-third of patients diagnosed with plaque psoriasis is younger than 20 years of age, and adolescents in particular have limited treatment options.
“Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents,” Janssen VP medical affairs Dr. Andrew Greenspan said. "With today's approval, Stelara has the potential to make a meaningful difference in the lives of these young adults."
FDA approves Glenmark’s Emend generic
SILVER SPRING, Md. — The Food and Drug Administration has approved Glenmark Pharmaceuticals’ generic Emend (aprepitant) capsules. The drug is indicated to prevent nausea and vomiting in patients undergoing chemotherapy.
Glenmark’s generic will be available in 40-, 80- and 125-mg dosage strength capsules. The product had branded and generic U.S. sales of approximately $64.9 million for the 12 months ended August 2017, according to QuintilesIMS data.
CVS Health, Epic partner on insights to bring care team together
WOONSOCKET, R.I. — CVS Health’s latest partnership is looking to make it easier for prescribers to see lower-cost alternatives through analytics and data sharing. The company is working Epic, whose Health Planet population health and analytics platform creates insights around medication dispensing patterns and adherence behaviors.
“This collaboration with Epic will enable us to continue to drive leading edge technology innovation beyond the pharmacy to the full health care system," CVS health chief information officer Stephen Gold said. “Together, our two companies will also examine opportunities to streamline and improve data sharing and linkages across the health care system to enhance communication and connectivity among patients, their physicians, the pharmacy and health insurers.”
The companies said the partnership would help improve decision-making abilities for patients and their care teams — including physicians, pharmacists and payers. Real-time benefit information and point-of-prescribing prior authorization will be provided in an effort to simplify access to necessary medications for patients and ensure that their prescribers are aware of a prescription’s formulary status and less expensive alternatives.
“At CVS Health we recognize that EHRs offer healthcare providers easier and more comprehensive access to their patients' information than ever before,” CVS Health chief medical officer Dr. Troyen Brennan said. “This new relationship will help us further expand how we work with Epic and providers on their EHR system to develop meaningful tools and programs that will ultimately help us take even better care of the patients we support.”
The partnership will allow CVS Health and Epic to explore improved prescribing decisions through the development of a comprehensive clinical database to enhance medication counseling and help optimize medication selection for CVS Health patients. The companies also will look into a shared care plan for pharmacists, which would improve pharmacist access to clinical information and allow contribution to the care plan. The collaboration also will explore digital front-store capabilities to enable over-the-counter and durable medical equipment to be included in a patient’s HER.
"CVS Health is one of the leaders in using data to dissolve domain silos, while offering new sources of intelligence and expertise that can better inform care delivery, reduce administrative overhead, and lower costs for patients,” Epic VP Population Health Alan Hutchison said.