FDA approves first-in-class antibiotic

Related tags Antibiotic resistance

The Food and Drug Administration's (FDA) approval of the
first-in-class antibiotic, Tygacil (tigecycline), is set to provide
doctors with an alternative treatment for skin and intra-abdominal
infections that have previously been hampered by the emergence of
drug-resistant bacteria.

Antibiotic resistance costs US society between $4 billion and $5 billion annually. According to the CDC, antibiotic resistance has become so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics.

Tygacil (tigecycline), the first antibiotic approved in a new class called glycylcyclines, was developed by Wyeth to overcome key mechanisms of resistance that have affected antibiotic use. Its main activity is against the drug-resistant bacteria methicillin-resistant Staphylococcus aureus (MRSA).

Tygacil is also indicated for the treatment of complicated intra- abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) in adults.

Tygacil has been a drug that industry analysts have tipped as the one to watch. For years, big drug firms have shied away from antibiotics. However, over the past six months, Wyeth has been touting the drug as one of the gems in its pipeline, with potential peak sales of $1 billion.

The drug could potentially go up against Vicuron's dalbavancin, an anti bacterial drug that has been a bargaining chip in a deal that saw Pfizer buy Vicuron Pharmaceuticals, for $1.9 billion (€1.6 billion) in cash last week. This move places the drug company further into the realms of anti-infective R&D - an area thought to be falling out of favour in the pharmaceutical industry.

The launch of these similar drugs by big pharma has signalled a big reversal in the drug business. Over the past few decades, many of the biggest drug firms, including Eli Lilly, Wyeth and Roche, seemed to back away from antibiotic development, closing plants and shuttering programs.

The revival has also seen Johnson & Johnson recently purchasing Peninsula Pharmaceuticals, another developer of antibiotics. Even biotech has entered late in the game with Cubist Pharmaceuticals now selling Cubicin, a first-in-class injectable bacteria killer it licensed from Lilly

"Life threatening infections are a growing concern globally,"​ says Dr Joseph Camardo, senior vice president, global medical affairs, Wyeth Pharmaceuticals.

"Bacterial infections are becoming more difficult to treat, with resistant strains on the increase. The approval of Tygacil will provide physicians with an important option for patients with complicated skin, skin structure, and intra-abdominal infections,"​ he added.

The supposed revival of anti-infectives follows a period in which few broad-spectrum antibiotic agents are currently in development. Antibiotic development has slowed to the point that FDA has had few opportunities to approve new agents. Development and approvals of new antibacterial agents have decreased by 56 per cent over the past 20 years (1998-2002 vs. 1983-1987).

The Tygacil New Drug Application (NDA) submission included data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of cIAI and cSSSI. The submission also included in vitro data showing activity against both gram-negative and gram-positive bacteria, anaerobes, and certain drug-resistant pathogens.

Wyeth now awaits decisions on approval of Tygacil from other regulatory bodies around the world. Tygacil was accepted by the European Medicines Agency (EMEA) for review, and Wyeth has filed for approval in other countries, including Brazil, Canada, Colombia, Mexico, Switzerland, Taiwan, and Venezuela.

The Australian Therapeutic Goods Administration and the South African Medicines Control Council (MCC) granted priority evaluation to Tygacil.

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