Orphan designation: Odronextamab Treatment of diffuse large B-cell lymphoma, 18/07/2022 Positive
Overview
This medicine was designated as an orphan medicine for the treatment of diffuse large B-cell lymphoma in the European Union on 18 July 2022.
This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.
Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:
Odronextamab is a bispecific monoclonal antibody, a type of protein designed to recognise and attach to two specific proteins on certain cells in the body. Odronextamab attaches to CD20, a protein present on the surface of B cells (a type of cell in the immune system) including the cancer cells. It also attaches to CD3, a protein present on T cells (a different type of cell in the immune system). When the medicine has attached to CD20 and CD3, it is expected that the T cells are activated and kill the CD20-expressing cancer cells, thereby eliminating or slowing down progression of the disease.
Based on description provided by sponsor
At the time of submission of the application for orphan designation:
- The effects of the medicine had been evaluated in experimental models.
- Clinical trials with the medicine in patients with diffuse large B-cell lymphoma were ongoing.
More information on how potential new medicines are tested during their development is available on Authorisation of medicines.
Medicines intended for rare diseases can be granted an orphan designation during their development.
The orphan designation allows the developer to benefit from:
- scientific and regulatory support to advance their medicine to the stage where they can request marketing authorisation;
- market exclusivity once the medicine is on the market.
To qualify for orphan designation, a medicine must meet a number of criteria:
- it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;
- the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development;
- there are no satisfactory alternative methods for the diagnosis, prevention or treatment of the condition or, if such a method exists, the medicine is of significant benefit to those affected by the condition.
EMA's Committee for Orphan Medicinal Products (COMP) is responsible for issuing opinions on applications for orphan designations.
The Agency sends the COMP opinion to the European Commission, which is responsible for granting the orphan designation. The full list of orphan designations is available in the Community register of orphan medicinal products for human use.
For more information, see:
EMA list of opinions on orphan medicinal product designation
EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
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