In 2015, the FDA’s Center for Drug Evaluation and Research (CDER) approved 45 new molecular entities – the highest annual number of new drugs to be approved in the past decade (up from 41 in 2014). The new approvals include 16 first-in-class drugs spanning 14 different medical conditions. Many of the new drugs were approved under one or more of the FDA’s 4 expedited pathways (fast track, breakthrough, priority review, and accelerated approval). Nearly half are for the treatment of rare diseases that affect 200,000 or fewer Americans.
A number of the new drugs treat various cancers, including multiple myeloma, lung cancer, melanoma, basal cell carcinoma, neuroblastoma, breast, colorectal, and thyroid cancers. The new approvals also include drugs for heart failure, high cholesterol, irritable bowel syndrome, hepatitis C, and cystic fibrosis, as well as a reversal agent for the oral anticoagulant dabigatran.
This issue provides detailed reviews of 2 PCSK9 inhibitors for LDL cholesterol lowering; 2 products for irritable bowel syndrome with diarrhea; a drug for hypoactive sexual desire disorder in premenopausal women; a selective uric acid reabsorption inhibitor for patients with gout; and a novel treatment for severe eosinophilic asthma. Four new oral cancer drugs – 2 for nonsmall cell lung cancer and 2 for multiple myeloma – are also briefly reviewed. Usual doses and selected drug interactions are summarized in Table 1. Nine more new drugs that are likely to be relevant in everyday practice are described in Table 2. Both tables include pronunciation guides.
- Pharmacists, Nurse Practitioners, Clinical Nurse Specialists, and Registered Nurses
This CE activity was developed by The Rx Consultant, a publication of Continuing Education Network, Inc.
CE activities for Pharmacists and Pharmacy Technicians:
This continuing education (CE) activity meets the requirements of all state boards of pharmacy for approved continuing education hours. CE credit is automatically reported to CPE Monitor.
CE activities for Nurse Practitioners and Clinical Nurse Specialists:
This continuing education activity meets the requirements of:
The American Nurses Credentialing Center (ANCC) for formally approved continuing education (CE) hours, and CE hours of pharmacotherapeutics.
The American Academy of Nurse Practitioners Certification Program (AANPCP) for acceptable, accredited CE.
This is a pharmacotherapeutics/pharmacology CE activity.
Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Requirements for CE Credit
- List the FDA approved indication(s), state the recommended dose(s), and discuss the evidence supporting the drug’s approval and its potential role(s) in therapy.
- Describe significant side effects and drug interactions. Provide 2-3 patient counseling tips.
- For each drug listed in Table 2: List the generic/brand names, dosage form(s), FDA approved indication(s), and major safety concerns.
James Chan, Pharm.D., PhD
Brief Bio : James Chan, PharmD, PhD, Pharmacy Quality and Outcomes Coordinator, Kaiser Permanente, Oakland, CA and Associate Clinical Professor, School of Pharmacy, University of California, San Francisco, CA.
Pamela Mausner, MD
Brief Bio : Pamela Mausner, MD; Medical Writer/Editor and Healthcare Advocate; and Associate Editor, The Rx Consultant.