Novel new drug approvals in 2011

Dr. D. Samba Reddy Wednesday, August 22, 2012, 08:00 Hrs[IST] Thirty new drugs have been approved by the US FDA in 2011 for marketing in the United States. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new indications for drugs already approved. Eleven of the thirty NMEs were new drugs approved for orphan diseases, while twelve are considered first-in-class drugs with a unique new mechanism of action. During 2011, the US FDA approved many unique and new drugs for chronic obstructive pulmonary disease, deep vein thrombosis, systemic lupus erythematosus (SLE), and epilepsy. In addition,several new biologicals were approved in the past year for the treatment of macular degeneration, acute lymphoblastic leukemia, Hodgkin lymphoma, melanoma, chronic hepatitis C, and SLE. The introduction of thirty NMEs in 2011 underscores a robust success rate. It confirms that innovation is once again beginning to pay off. Analysis of drug approvals reveals a unique new trend in drug discovery in the face of stiff competition from generic products and declining revenues. In the existing climate of reduced pipeline for NMEs, the future and survival of big companies rests heavily on their unique niche products and biologics with relatively less competition from generic manufacturers. However, the competition for biosimilars is growing by the hour and therefore, crafting innovative generic biologicals is vital for generic biotechnology companies. Although the number of NMEs approved in the past 10 years has been declining, there is a substantial increase in R&D expenditure for drug discovery. Overall, the new drug approval list unveils unique and emerging trends in drug discovery especially in the current generics era. New drugs approval declined substantially during the past few years New drugs are desperately needed for cancer, infectious diseases, neurological disorders and life-style conditions. The number of new drugs approved by the US FDA has declined substantially during the past few years, despite large increases in R&D investment for drug discovery and development. There is growing 'pipeline syndrome' for new drugs, while success is very limited for 'blockbuster' drugs with sales of over $1 billion. The pharma industry in the US has been scaled back. Many pharma and biotech companies are changing how they fill their new drug pipelines. In recent years they have trimmed their early discovery efforts and focused their resources on processes further downstream. New drug development begins with the identification of molecular targets that play a central role in a particular disease state. One key goal is the identification of an appropriate ligand that binds to a therapeutically relevant biological target. Four different strategies used to identify new lead candidates include phenotype screening, mechanistic or target-based screening, modification of natural agents and biologic-based approaches. Drug discovery is a tedious and difficult process and it takes about 5 to 10 years to introduce a new drug. It costs an estimated $1 billion for a new drug discovery. The failure of drug development or approval costs up to 80% of total R&D investment, typically from $100 to $700 million. Therefore, new drug discovery and development is a high-risk and high-reward business. In 2011, the US FDA approved many new and unique drugs for marketing in the United States. The new drug therapies were approved for chronic obstructive pulmonary disease (COPD), deep vein thrombosis (DVT), systemic lupus erythematosus (SLE), and epilepsy. In addition, a number of new biologicals were approved in the past year for infectious diseases and cancer therapy. This article provides a brief overview of the new drugs approved in 2011. The drug list contained in this article comprises of the current FDA-approved indications, pharmacology and related mechanistic information. Due to space constraints, an in-depth review of new drugs including clinical pharmacology, dosing guidelines, and adverse effects are beyond the scope of this article. Thispharmaceutical update is designed to focus attention on the growing trends in the new drugs and biologics approvals that may shed unique or emerging trends in drug discovery patterns. The 2011 novel new drugs brochure published by the Center for Drug Evaluation and Research (CDER) provides a broad overview of FDA approvals of new molecular entities for the calendar year 2011 (CDER, 2012).Sixteen of the 30 NMEs approved in 2011 have been reviewed in detail elsewhere (Mancano, 2012a; 2012b).