The Year's New Drugs & Biologics, 2011

Abstract

2011 was a good year in many respects for the pharmaceutical industry, especially regarding the approval and launch of several important new products. The FDA reported a record high rate of approvals during FY2011 (October 1, 2010-September 30, 2011), reflecting the agency's commitment to maintaining "a state-of-the-art drug approval process that brings important drugs to market quickly and efficiently" (1). While not all of the new drugs and biologics listed in FDA's fiscal year summary meet the criteria for inclusion in this article, most of them do, and hence are reviewed in the following pages. Also covered in this year's expanded article are new approvals and new launches in other global markets, line extensions and other developments of interest to the industry: generic drug approvals, product withdrawals and discontinuations, new developments in the area of orphan drugs and diseases, and more.

Natural product and natural product derived drugs in clinical trials

“…A total of 25 NP and NP-derived drugs were approved for marketing (Table 1) from January 2008 to December 2013 with 5 being classified as NPs, 10 as SS NPs, and 10 as NP-derived drugs, which include 2 NP-containing ADCs. [28][29][30][31][32][33][34][35][36][37][38][39][40] Previous reviews in this series have detailed NP-derived drugs launched from 1998 to 2004 10 . New NP drug pharmacophores will be discussed in detail in Section 9.…”

“…NP-derived drugs accounted for a meaningful number of the small molecule drug and ADC launches: 3 Table S1). From 2000-2013, there were 375 worldwide drug approvals, [28][29][30][31][32][33][34][35][36][37][38][39][40] which could be classified as 317 NCEs (54 NP-derived, 17%), 56 NBEs and 2 ADCs (2 NP-derived, 100%). On average, 24.4 new NCEs were approved each year with 4.1 being NP-derived.…”

Drug Repurposing: A Review

“…The novel drugs development is a time consuming and complex process. In which investment rate is high and success rate being small [13][14][15][16]. In recent years, decreases the new drugs development or approved for the clinical use.…”

A high‐content drug screening strategy to identify protein level modulators for genetic diseases: A proof‐of‐principle in autosomal dominant leukodystrophy

“…This approach has several advantages, namely (i) searching for an effective compound among chemicals that have already passed safety tests, avoiding 30% of clinical trial failures due to harmful compounds; (ii) the bioavailability and pharmacokinetics of the drugs are known; (iii) the cost of producing a repositioned drug is reduced when compared to that required for the discovery and development of a new drug; and (iv) the translation into clinical practice is faster. The effectiveness of this approach is demonstrated by the fact that more than 30% of new pharmacological products launched in recent years are line extensions of previously marketed compounds (Graul & Cruces, 2011; Graul et al, 2010, 2012; Graul, Cruces, et al, 2014; Graul, Navarro, et al, 2014), and many successes have been reported over the years, including amantadine for Parkinson's disease (Paquette et al, 2012), topiramate for essential tremor (Ondo et al, 2006), and Tourette syndrome (Jankovic et al, 2010), and very recently, lonaprisan in a mouse model of Pelizaeus‐Merzbacher disease (Prukop et al, 2014), and celecoxib for prevention and treatment of colon, breast, prostate, and head and neck cancers (Tołoczko‐Iwaniuk et al, 2019). The success of drug‐repositioning approaches is strongly related to the optimization of appropriate reporter cell lines and assays suitable for high‐throughput screening (HTS).…”