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Supply constraint of Creon® 10000 Creon® 25000 (Pancreatin)
4th July 2024

As the marketing authorisation holder and distributor of Creon® in the UK, we were notified by our third-party manufacturing partner, Abbott, of a supply constraint of Creon® (pancreatin) in the UK.

This constrained supply is due to high global demand and reaching maximum manufacturing supply output.

Creon® is a biologic product with a natural variation of its raw material and is made using a complex manufacturing process. The complexity of the process means that the ability to increase manufacturing capacity in the short-term is limited.

There is a long-term strategic initiative between Viatris and Abbott to increase the supply output of Creon® at the manufacturing facility. This work has already begun with expected completion in 2026.

During this supply constraint, we hope to be able to supply approximately 90-95% of the average monthly demand for Creon® lipase units into the market each month, until this supply constraint is resolved.

If you require additional information or have any questions, please contact customer services on 01707 853100 or via email; productenquiries@viatris.co.uk. For medical enquiries please contact our medical information team on 01707 853 000 or via email; info.uk@viatris.co.uk.

UK-CRE-2024-00006 July 2024

Viatris Connect
Keywords..

Chronic pancreatitis

Chronic pancreatitis is the most common cause of PEI – 80 to 90% of these patients will have some degree of PEI.1 In patients with chronic pancreatitis and severe PEI, digestive lipase output has been shown to be about 2.5 IU/min – less than 0.2% of normal (3,000 IU/min).1 In order to avoid steatorrhoea, lipase secretion of greater than 5 to 10% of normal is needed, precipitating the need for effective Pancreatic Enzyme Replacement Therapy (PERT).1

Creon® has been shown to improve symptoms associated with PEI

Creon® improved the following symptoms at 1 week and at 52 weeks versus baseline:2,3

Adapted from Thorat V et al. Aliment Pharmacol Ther 2012; Ramesh H. et al. Pancreatology 2013.

** Values are estimations taken from graphs within the published paper as exact values were unpublished.

There were also significant improvements at 52 weeks in coefficients of fat absorption (CFA) and nitrogen absorption (CNA) versus baseline:3

Trial Information
*1 week double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Patients >18 years with proven chronic pancreatitis and PEI (N=62) were randomised 1:1 to Creon® 40,000 or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in the coefficient of fat absorption (CFA) from baseline to the end of double-blind treatment (analysis of covariance). 51-week open-label extension (OLE): patients received Creon® 40,000 at a dose of 80,000 lipase units per main meal and 40,000 lipase units per snack. Clinical symptoms and CGI: reported by patients and assessed by investigators at baseline, the end of the double-blind phase and at weeks 5, 13, 26, 39 and 52. Quality of life: assessed with the SF-36® Health Survey questionnaire at baseline, end of double-blind phase, and at study end. The SF-36® comprises eight component scores and two summary scores, with higher scores indicating better quality of life.
**Values are estimations taken from graphs within the published paper as exact values unpublished.

Creon® has been shown to significantly improve patients’ nutritional status3

Several nutritional parameters significantly improved from baseline in patients with chronic pancreatitis.

Adapted from Ramesh H. et al. Pancreatology 2013
Dose of 80,000 lipase units/meal; 40,000 lipase units/snack; 6-9 capsules per day.

Creon® has been shown to improve quality of life as measured by the SF-36 Health Survey questionnaire3

At 52 weeks, patient quality of life had improved from baseline with statistically significant changes in:

  • bodily pain
  • general health
  • vitality
  • emotional well-being
  • mental health
  • mental component summary.

***p=0.001 vs. baseline; **p<0.01 v. baseline; *p<0.05 vs. baseline.
Adapted from Ramesh H et al. Pancreatology 2013
OLE: Open-label extension – 52 weeks.

References

  1. Keller J, et al. Human pancreatic exocrine response to nutrients in health and disease. Int J Pancreatol. 2005; 54(Suppl 6): 1-28
  2. Thorat V, et al. Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2012; 36(5): 426-436
  3. Ramesh H, et al. A 51-week, open-label clinical trial in India to assess the efficacy and safety of pancreatin 40000 enteric-coated minimicrospheres in patients with pancreatic exocrine insufficiency due to chronic pancreatitis. Pancreatology. 2013; 13(2): 133-139
  4. Imrie CW, et al. Review article: enzyme supplementation in cystic fibrosis, chronic pancreatitis, pancreatic and periampullary cancer. Aliment Pharmacol Ther. 2010; 1:1-25.

> 80% of patients can be treated adequately with normal food supplemented by pancreatic enzymes.4

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Adverse reactions/events and device failures should also be reported to MAH at e-mail address: pv.uk@viatris.com.

This website is intended for UK healthcare professionals. If you are a patient who has been prescribed Creon® please click here

Viatris UK Healthcare Limited (company registration number 09189103), an English company with a registered office address at 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL (VAT - 421 623 781).

Creon® is indicated for the treatment of pancreatic exocrine insufficiency.

CRE-2021-0769 December 2023.

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