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EMEA Recommends Information on Lung Cancer Cases to Be Included in Exubera Product Information

LONDON, 17 June 2008--The European Medicines Agency (EMEA) has recommended that the product information for Exubera be updated with new information on cases of lung cancer seen in patients taking the medicine. Exubera, from Pfizer Limited, is a fast-acting insulin powder for inhalation, used for the treatment of adults with type 1 or type 2 diabetes.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed the information on cases of lung cancer as part of the continuous monitoring of medicines. A total of seven cases of lung cancer associated with the use of Exubera have been reported. Five of the cases occurred in patients who took Exubera in clinical studies comparing the medicine with other diabetes treatments (corresponding to 3,800 patient-years of exposure). In contrast, lung cancer was diagnosed in one patient who had taken a comparator medicine, out of 3,900 patient-years of exposure. One additional case was reported in a study where Exubera was not compared with other treatments. The remaining case was reported in a patient who received the medicine once it was available on the market. All of the lung cancer cases occurred in patients who had been cigarette smokers.

The relatively small number of cases and the limited information provided, as well as the fact that they only occurred in patients who had been smokers did not allow the CHMP to establish a causal relationship between the cases of lung cancer and treatment with Exubera. However, as a precautionary measure, the CHMP recommended to update the product information. In addition, the Committee requested the marketing authorisation holder to perform a study to look at the possible risk of lung cancer developing in patients who have taken Exubera.

The marketing authorisation holder stopped distribution of Exubera in January 2008 for commercial reasons. It is expected that the medicine will no longer be available in the European Union from September 2008.

-- ENDS --

Notes:

1. More information is available in a question-and-answer document. Please see below for the document.

2. Exubera was first authorised in the European Union on 24 January 2006. More information about the medicine is available in the European Public Assessment Report (EPAR), which can be found at: http://www.emea.europa.eu/humandocs/Humans/EPAR/exubera/exubera.htm

3. One patient-year is the equivalent of one patient taking the medicine for one year.

4. This press release, together with other information on the work of the EMEA, can be found on the EMEA website: www.emea.europa.eu

Media enquiries only to:

Martin Harvey Allchurch or Monika Benstetter

Tel. (44-20) 74 18 84 27, E-mail press@emea.europa.eu

European Medicines Agency
Press office
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09
E-mail: mail@emea.europa.eu  http://www.emea.europa.eu

European Medicines Agency

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

© European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

QUESTIONS AND ANSWERS ON EXUBERA

As part of its continuous monitoring of medicines, the European Medicines Agency (EMEA) has reviewed new information on a small number of cases of lung cancer seen in patients who have taken Exubera.

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that it was not possible to determine whether the cases were related to the use of Exubera or not, because there were too few cases of lung cancer, all of the cases were in former smokers, and the information provided about the cases was limited. However, as a precautionary measure, the Committee has recommended that the prescribing information for Exubera be updated to include the information on these lung cancer cases.

What is Exubera?

Exubera is a fast-acting insulin powder for inhalation (breathing in). The active substance in Exubera is a copy of human insulin. Exubera is used for the treatment of adults with type 1 or type 2 diabetes.

These are diseases in which the body does not produce enough insulin to control the level of blood glucose (sugar) or when the body is unable to use insulin effectively. The marketing-authorisation holder (the company that makes Exubera) is Pfizer Limited. Pfizer stopped supplying Exubera to pharmacies on 18 January 2008 for commercial reasons. Some stocks of Exubera are still available but all patients need to switch to other diabetes medicines by September 2008, when supplies of Exubera are expected to run out.

What is the issue with Exubera?

There have been a total of seven cases of lung cancer diagnosed in patients who have taken Exubera. Five of these cases were in studies comparing Exubera with other diabetes treatments, out of 3,800 ‘patient-years’ of exposure to the medicine. In contrast, lung cancer was diagnosed in one patient who had taken a comparator medicine, out of 3,900 patient-years of exposure. One ‘patient-year’ is the equivalent of one patient taking the medicine for one year.

There was also another case of lung cancer in a study where Exubera was not compared with any other treatment. The last case was reported in a patient not in a study, who received the medicine once it was on the market.

All of the lung cancer cases occurred in patients who had been cigarette smokers.

Because the number of cases is small and because they only occurred in former smokers, the CHMP could not determine whether the lung cancer cases were related to Exubera or not. However, the Committee could not exclude the possibility that there could be a relationship between Exubera and lung cancer.

What action is the EMEA taking?

As a precautionary measure, the CHMP has recommended that the product information for Exubera be updated to include the new information on the lung cancer cases. This information will enable patients and their doctors to decide whether to continue using Exubera while the medicine is still available.

What will happen next?

The company that makes Exubera is planning a study to look in more detail into the possible risk of lung cancer developing in patients who have taken Exubera.

This study is expected to involve the patients who have taken part in studies of Exubera over the last five years and to follow these patients up for up to two years.

As soon as more information becomes available, the EMEA will update the information on Exubera.

What is the advice to patients and doctors?

• As supplies of Exubera will not be available in the near future, patients who are still taking it should talk to their doctor about switching to other treatments for diabetes.

• Doctors should contact any of their patients who are still taking Exubera to discuss other treatment options.

• Patients who have taken Exubera in the past and have any concerns should speak to their doctor or pharmacist.

Posted: June 2008


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