Pipeline

Last year witnessed a new high in the number of US Food and Drug Administration (FDA) approvals of pharmaceuticals, including new molecular entities (NMEs) and new Biologic License Applications (BLAs). This surge in approved drugs, along with therapies in the pipeline, suggests a period of optimism as more medicines come online.
“Innovation drives progress,” suggests the US Food and Drug Administration (FDA) in its report on the 41 new molecular entities and new biologic pharmaceuticals that were approved in 2014.
For patients, newly approved drugs represent exciting opportunities to treat serious disease states, many of which have had few treatment options available. New therapies have enabled physicians to initiate treatment earlier and to continue treatment throughout the disease progression. The goal of early therapy is to alleviate the long-term effects of chronic or life-threatening conditions, but when treatment occurs earlier and lasts longer, the cost of therapy also increases.

Chicago, IL—ASCO 2012 was replete with data on emerging therapies currently in development. The key findings presented at the meeting are summarized below.

This article outlines some of the novel therapies recently approved by the US Food and Drug Administration (FDA) or are furthest along in clinical trials for type 2 diabetes.

Dipeptidyl Peptidase-4 Inhibitors

The cancer drug pipeline is bursting with promising new therapies for a variety of tumors. Of the many investigational drugs presented at ASCO 2011, some of the most promising agents now in phase 2 or 3 clinical trials are discussed below and throughout this special issue.

Among a host of investigational drugs for the treatment of cancer featured during the 2010 meeting of the American Society of Clinical Oncology, the following agents were highlighted as showing great promise.

Crizotinib: Although targeting only a small subset of patients with non–small-cell lung cancer (NSCLC), the investigational agent crizotinib—an oral inhibitor of the ALK gene, which is mutated in about 5% of patients with NSCLC—produced unprecedented response rates in a phase 2 study.

Although promising late-stage drugs in the cardiovascular (CV) pipeline are few, increasing numbers of pharmaceutical manufacturers are taking a stab at oral, fixed-dose alternatives to warfarin, many of which are in phase 3 clinical trials. The following agents were featured at special sessions at the 2010 annual meeting of the American College of Cardiology (ACC).

Unique Factor X Inhibitor

At the 2010 annual meeting of the American Academy of Neurology (AAN), the largest explosion of new agents in development was for multiple sclerosis (MS), the second most common neurologic disability in young and middle-aged adults.

At the recent 2010 Digestive Disease Week (DDW) meeting, positive data were presented for several investigational drugs close to approval for gastrointestinal (GI) disorders, including hepatitis C virus (HCV), Crohn’s disease, irritable bowel syndrome (IBS), and constipation. 

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