Neofordex

Neofordex can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of multiple myeloma.

Neofordex is available as 40 mg tablets. The usual dose is 40 mg once a day, taken preferably in the morning. However, the dose and how frequently Neofordex is given varies depending on the medicines it is given with and the patient’s condition. For further information, see the package leaflet.

The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids. In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells. It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death. Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.

Because the effects of high-dose dexamethasone in multiple myeloma are well established, the company for Neofordex presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.

In addition, a bioequivalence study was carried out in 24 healthy volunteers which showed that Neofordex has comparable quality to the reference medicine, Dectancyl.

The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood sugar levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), tiredness, oedema (swelling) and weight increase. Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression. For the full list of all side effects reported with Neofordex, see the package leaflet.

Neofordex must not be used in patients with active viral disease (especially hepatitis, cold sores, shingles or chicken pox) or with uncontrolled psychoses (altered sense of reality). For the full list of restrictions, see the package leaflet.

A risk management plan has been developed to ensure that Neofordex is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the .

The European Commission granted a marketing authorisation valid throughout the European Union for Neofordex on 16 March 2016.

For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established. The CHMP therefore decided that Neofordex’s benefits are greater than its risks and recommended that it be approved for use in the EU.

Neofordex is a medicine used together with cancer medicines to treat adults with multiple myeloma who have developed symptoms. Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body’s natural defences).

Neofordex contains the active substance dexamethasone. It is a ‘hybrid medicine’. This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength. The reference medicine for Neofordex is Dectancyl.

The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Neofordex.

If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.

Neofordex is a corticosteroid medicine that contains the active substance dexamethasone. It was to be available as 40 mg tablets.

Neofordex was to be used in combination with other medicines to treat adult patients with multiple myeloma who have developed symptoms. Multiple myeloma is a cancer of the plasma cells in the bone marrow.

Neofordex was developed as a 'hybrid medicine'. This means that it was intended to be similar to a 'reference medicine' containing the same active substance, but in a higher strength. While the reference medicine Dectancyl is available as 0.5 mg tablets, Neofordex was to be available as 40 mg tablets.

Neofordex was designated an 'orphan medicine' (a medicine to be used in rare diseases) on 6 June 2010 for the treatment of multiple myeloma.

The active substance in Neofordex and Dectancyl, dexamethasone, belongs to a group of medicines known as corticosteroids, which reduce the activity of the immune system (the body's natural defences) by attaching to receptors in various types of immune cells. In multiple myeloma, high-dose dexamethasone is used together with chemotherapy to make chemotherapy more effective and to reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting. In addition, by providing a high dose in a single tablet Neofordex was expected to simplify dosing.

Because Neofordex was assessed as a hybrid medicine, and the effects of high-dose dexamethasone in multiple myeloma are well established, the company presented the results of a study carried out to investigate whether it is bioequivalent to the reference medicine, Dectancyl. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. The company also presented studies from the literature on the use of dexamethasone for the treatment of multiple myeloma.

The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. The company had not yet responded to the last round of questions at the time of the withdrawal.

Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Neofordex could not have been approved for the treatment of multiple myeloma. The Committee considered that controls to ensure suitable and consistent quality of the medicine have not been shown to be adequate. Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Neofordex did not outweigh its risks.

In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application since it would not be possible to provide the additional data regarding the quality of the medicine within the timetable required by the procedure.