CHMP Meeting Highlights March 2025
In the month of March 2025, medicinal products for the following indications have received a positive opinion:
- Myopia in children
- Elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease
New medicines recommended for approval
Ryjunea (atropine) has received a positive opinion for the slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.
Myopia or nearsightness is a common condition and the causes are an elongated eyeball (from front to back) or a too steeply curved cornea. Myopia can worsen as the children grow.
Xoanacyl (Ferric citrate coordination complex) has received a positive opinion for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).
In patients with CKD the kidneys don’t function normally and can’t remove enough phosphate from the blood leading to increased serum phosphorous levels. Permanent increased serum phosphorous can lead to secondary malignancies like arteriosclerosis, increased risk bone fractures and muscle spasms. Iron deficiency anemia is a condition where not enough iron in form of hemoglobin is present in the blood. Symptoms of anemia are fatigue, shortness of breath and lack of energy.
Recommendations on extensions of therapeutic indication
Bosulif (bosutinib): extension of indication for Bosulif to include
- adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
- Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
- Adult patients with CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Previously Bosulif was only approved in adult patients.
Calquence (acalabrutinib): extension of indication for Calquence to include in combination with bendamustine and rituximab the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).
Calquence is also approved for the treatment of chronic lymphocytic leukaemia.
Flucelvax (Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)): extension of indication for Flucelvax to include the prophylaxis of influenza in adults and children from 6 months of age.
Previously the age limit was 2 years.
Opdivo (nivolumab): extension of indication for Opdivo to include:
Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%.
Opdivo is already approved for the treatment of different other cancer types.
Tevimbra (tislelizumab): extension of indication for Tevimbra to include in combination with etoposide and platinum chemotherapy the first-line treatment of adult patients with extensive-stage small cell lung cancer.
Tevimbra is already approved for the treatment of non-small cell lung cancer in different settings.
Tremfya (guselkumab): extension of indication for Tremfya to include the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.
Tremfya is already approved for the treatment of plaque psoriasis and psoriatic arthritis.
Xydalba (dalbavancin): extension of indication for Xydalba to include the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth.
Previously the age limit was 3 months.
Other topics
AIM-MASH: first positive qualification opinion for an artificial intelligence tool to diagnose inflammatory liver disease in biopsy samples to use in clinical trials.
The tool helps pathologists to identify abnormalities in liver biopsies called MASH (metabolic dysfunction associated steatohepatitis).
MASH is a build up of fat in the liver leading inflammation and scarring over time. Untreated MASH can severely damage the liver. It develops independent from significant alcohol usage and risk-factors are obesity, type 2 diabetes, high blood pressure, abnormal cholesterol, and belly fat.
A press release was published by the EMA.
Newly published EPARs
The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:
Andembry
Andembry is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.
Lazcluze
Lazcluze in combination with amivantamab is indicated for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
Rytelo
Rytelo is indicated as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
Seladelpar Gilead
Seladelpar Gilead is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
Wainzua
Wainzua is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.
Welireg
Welireg is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.
Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.
More information
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