Abbott Labs: FDA Panel Backs Humira for Colitis, Gets Additional Treatment Approval In Europe

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Abbott Laboratories

A U.S. Food and Drug Administration (FDA) advisory panel has backed the use of Abbott Labs‘ (NYSE:ABT) largest selling drug Humira for the treatment of Ulcerative Colitis (UC) even as the FDA staff has recently raised some concerns about the drug. [1] In a separate event, the drug got European approval for the treatment of moderately active Crohn’s disease (a form of inflammatory bowel disease that affects intestine). [2] All of these events lend support to our expectations of continued growth in sales of Humira in near future.

We have recently revised our price estimate for Abbott Labs to $67. For further details, please read our note here.

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Recently, the FDA staff had raised concerns that, for the treatment of UC, Humira doesn’t show strong benefits over JNJ & Merck’s Remicade even as safety risks remain the same. Moving patients from an effective treatment to potentially less effective treatment wouldn’t be prudent. However, the FDA advisory panel has voted in favor of the drug saying the benefits outweigh the risks. While the FDA is not bound to accept the recommendations of advisory panel, we expect the company to eventually receive the approval by the beginning of next year, which has been delayed several times this year.

The European Commission’s approval for Humira’s use in moderately active Crohn’s disease will add an additional revenue stream for the drug. Continuance of such approvals would lend support to Abbott’s efforts to expand the drug’s base to new indications to overcome increasing competition and new entrants in the key Rheumatoid Arthritis market where Humira remains a distinguished leader.

Humira has been a phenomenal drug for Abbott. It is the world’s best-selling drug in the autoimmune market, with an estimated market share of over 30% in the near $25 billion autoimmune market. Other indications for which Humira is approved in the U.S. include Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Juvenile Idiopathic Arthritis, and Plaque Psoriasis.

Humira’s revenues exceeded $8 billion in 2011, and we expect it to top $10 billion by 2013. Thereafter, we expect the revenues to gradually decline as competition penetrates the market. Pfizer is getting ready with its oral drug tofacitinib, while Roche recently reported better efficacy results for monotherapy RA patients. Recently, Belgium-based company Ablynx also claimed to show benefits over Humira.

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  1. Abbott’s Humira Backed By FDA Advisory Panel For Colitis, Bloomberg, August 29 2012 []
  2. Abbott’s Humira cleared for Crohn’s disease in EU, thepharmaletter, August 31 2012 []