FDA
18th March 2014

AdCom Roll Call Special – Spotlight on: GIDAC

The Gastrointestinal Drugs Advisory Committee (GIDAC) guides FDA policy regarding the safety and effectiveness of marketed.

AdCom Roll Call Special – Spotlight on: GIDAC

The Gastrointestinal Drugs Advisory Committee (GIDAC) guides FDA policy regarding the safety and effectiveness of marketed and investigational drug products for use in the treatment of various gastrointestinal diseases. The GIDAC consists of a core 11 voting members, including the chair. This committee currently has no vacancies, and many of the current members have been with the GIDAC for over a year.

The GIDAC has not yet held a meeting this year, and met only one time in 2013. This is especially surprising, as each FDA Advisory Committee is expected to meet approximately four times a year. The meeting of the GIDAC in 2013 was jointly held in December with the Drug Safety and Risk Management Advisory Committee (DSaRM). The meeting’s purpose was to discuss two biologics license applications (BLAs) for vedolizumab (Takeda Pharmaceuticals, USA Inc.): one for the treatment of adult patients with moderately to severely active ulcerative colitis and one for the treatment of adult patients with moderately to severely active Crohn’s disease. The committees voted to recommend the drug’s approval for both of these indications. The FDA has yet to formally approve the drug, but will likely do so sometime this year.

For more info on this meeting, click here.

The recommendation for vedolizumab’s approval comes at an important time for the gastrointestinal (GI) therapeutics market. The GI therapeutics market is one of the most mature and reflects a high degree of generalization; patent expirations among GI drugs are leading to a decrease in market growth. This may be why the GIDAC has met so infrequently over the last year – there is a lack of new innovative therapies seeking FDA approval. Over the years, the growth of the GI therapeutic area has traditionally depended on the performance of the proton-pump inhibitor (PPI) drug class, which is used to treat conditions such as peptic ulcer disease and gastroesophageal reflux disease. Many of the drugs in this class such as Prilosec (AstraZeneca) and Prevacid (Novartis) have since loss patent protection and generic versions are now widely available.

Research and development efforts in the GI therapeutics market are now shifting to areas of unmet medical need; conditions such as irritable bowel syndrome (IBS), Crohn’s disease (CD) and ulcerative colitis (UC). Therefore, over the next decade, it is expected that the GI drug market’s growth will be determined by the growth of immunosuppressants and antirheumatic agents. These two drug classes are led by the currently approved biologics Remicade (Janssen Biotech, Inc.) and Humira (Abbott Laboratories), both for the treatment of CD and UC. Vedolizumab (trade name Entyvio) is the newest drug of this type to receive a vote of approval from the GIDAC.

According to a recently published report by GBI Research, almost 51% of the current global market GI pipeline is in Phase II and Phase III development, of which 19 molecules are indicated for the treatment of IBS, 48 for UC and 41 for CD. As GI therapeutic market dynamics are shifting from PPI’s to complex biologics for the treatment of conditions with greater unmet medical need (IBS, CD and UC), we are likely to see more meetings of the GIDAC in the years ahead. Companies that have maintained a more diverse GI drug class portfolio are expected to gain more of the GI therapeutic market share in the long run. Do you anticipate a meeting with the GIDAC in the coming years?

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