Solution for injection for the treatment of primary hyperoxaluria type 1 (PH1) in adults and children in all age groups

Information on authorisation

The medicinal product OXLUMO contains the active substance lumasiran.

OXLUMO is used to treat primary hyperoxaluria type 1 (PH1) in adults and children in all age groups.

PH1 is a rare disease in which the liver produces too much of a certain substance, called “oxalate”. The kidneys remove oxalate from the body, excreting it in the urine. In people with PH1, the additional oxalate can accumulate in the kidneys and result in kidney stones and impaired kidney function. Oxalate can also accumulate in and cause damage to other parts of the body, including the eyes, heart, skin, and bones.

Since primary hyperoxaluria type 1 is a rare and life-threatening disease, the medicine OXLUMO has been authorised as an orphan drug. The term "orphan drug" is used to refer to important medicines for rare diseases.

OXLUMO has been authorised by Swissmedic under Article 13 of the Therapeutic Products Act (TPA). This means that the medicinal product is already authorised in another country with comparable medicinal product control.

In this case, Swissmedic takes into consideration the results of checks carried out by foreign regulatory agencies, provided certain requirements are fulfilled. These involve checks on the quality, efficacy, and safety of the medicinal product, and the extent to which the results can be accepted for Switzerland. The consideration of the results of foreign authorisation procedures is intended to help ensure that medicines that are already authorised abroad can be made available to patients in Switzerland as quickly as possible.

In deciding whether to authorise OXLUMO in Switzerland, Swissmedic accepted the assessment and approval decision of the European Medicines Agency (EMA; reference number EMA/568312/2020) and has only conducted a limited scientific review.

Accordingly, in the SwissPAR (Swiss Public Assessment Report) and the resulting Public Summary SwissPAR, Swissmedic refers to the publicly available Assessment Report issued by the reference authority: www.ema.europa.eu.

Further information on the medicinal product

Information for healthcare professionals:

Information for patients (package leaflet): 

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.}

^{New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}