Problem at UK API plant not Italian site says GSK

GSK API "issue" will limit supplies of Allergan's superbug buster Avycaz

By Gareth Macdonald contact

- Last updated on GMT

GSK makes Avycaz at Italy site, but says shortage due to issue at UK API facility (source Google maps)
GSK makes Avycaz at Italy site, but says shortage due to issue at UK API facility (source Google maps)

Related tags: Antibiotic resistance, United kingdom, Allergan

An issue at a GSK API manufacturing site will limit supplies of the superbug busting antibiotic Avycaz for the next six months according to drug manufacturer Allergan.

The Avycaz (ceftazidime-avibactam) shortage was to the US Food and Drug Administration (FDA) last week by Allergan’s subsidiary Cerexa​ Inc.

The firm cited a “shortage of active ingredient​” as the reason and said supplies would be limited until February 2017.

According to a document​ on Allergan’s website UK drug manufacturer GSK makes the combination drug at a facility in Verona, Italy.

In a prepared statement GSK said: “As soon as we realised there was an issue with the supply we contacted Allergan we have been in regular communication since. We are working hard to resolve the issue as soon as possible.​” 

A GSK spokeswoman confirmed the firm makes the API avibactam for Avycaz, but said the unspecified issue occured at a primary manufacturing site in the UK rather than the secondary production site in Verona.

Sales

Avycaz – which was approved in the US last June -is used to treat complicated intra-abdominal Infections (cIAI) and urinary Tract Infections (cUTI) caused by bacteria resistant to other antibiotics.

The product generated revenue of $13.7m (€12.1m) in the US in the second quarter according to financials released by Allergan last week.

Allergan did not respond to a request for comment.

Avycaz 

Avycaz was developed by Actavis, now Allergan, in collaboration with AstraZeneca.

AstraZeneca has rights to sell it in Europe where it was approved in June​ under the brand name Zavicefta.

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