Vijoice (alpelisib)

Where it stands

Vijoice (alpelisib) is authorised in the EU. The European Commission decision is dated 15 July 2026, and the marketing authorisation holder is Novartis Europharm Limited. The CHMP positive opinion came earlier, on 21 May 2026.

The authorised indication is the treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS). The records classify the product under Genetic Diseases, Inborn and Growth Disorders.

The records also list two other EU entries for the same substance: Piqray (Authorised) and an earlier Vijoice entry marked 'Application withdrawn'. The records do not say why that application was withdrawn or how it relates to the current authorisation.

Regulatory pathway and designations

The product carries three designations: Orphan, Conditional and Additional monitoring. The sequence is the standard EU route. The CHMP adopts a scientific opinion, and the Commission then issues a legally binding decision that applies across the EU. Here the two steps were about eight weeks apart (21 May to 15 July 2026).

A conditional marketing authorisation is generally granted on less complete data than a standard one. It is used where the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk of the remaining data gaps. It is valid for one year and renewed annually. The holder must complete specific obligations, usually further studies, within set timelines. The records do not list the obligations for Vijoice.

The orphan designation reflects the rarity and seriousness of the condition. In general it can bring incentives such as protocol assistance and a period of market exclusivity. The records do not say what exclusivity applies or whether orphan status was reviewed at the time of approval.

Safety and pharmacovigilance

The records contain no safety data. They give no adverse reaction profile, contraindications, risk management plan content or post-authorisation safety study requirements, so none can be assessed here.

The records do show that the product is under additional monitoring. This is generally signalled by a black inverted triangle in the product information. It means the product is subject to intensified safety surveillance, and healthcare professionals and patients are encouraged to report suspected adverse reactions.

Together with the conditional status, this means the benefit-risk balance will be reassessed as further data accrue. The detailed safety conclusions are in the product information and the EPAR, which are not part of these records.

What to watch

The first point is the conditional authorisation. Watch for the annual renewal and for the completion of the specific obligations. A later conversion to a standard marketing authorisation would depend on the data being confirmed. The records give no dates or details for these steps.

The second point is how Vijoice relates to the other alpelisib entries in the EU. The records show Piqray as authorised and an earlier Vijoice application as withdrawn. Professionals should check that the product information, and any lifecycle changes, are applied to the right product.

Market access is not covered by the records. Launch timing, national pricing and reimbursement decisions, and any real-world evidence plans would need other sources.