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SMC ID Date Medicine Submission Type Indication
SMC2622 13/05/2024 budesonide/formoterol (Symbicort) Full

Symbicort Turbohaler 200/6 as reliever therapy for adults and adolescents ≥12 years with mild asthma 

SMC2671 13/05/2024 zanubrutinib (Brukinsa) SMC2671 Non submission

In combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

SMC2634 13/05/2024 ruxolitinib (Opzelura) Full

For treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age

SMC2558 08/05/2024 Tixagevimab and cilgavimab (Evusheld) Collaboration

Treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

SMC2550 08/05/2024 remdesivir (Veklury) Collaboration

treatment of COVID-19 in:

    • adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).

    • adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

SMC2610 08/04/2024 ritlecitinib (Litfulo) Full

Treatment of severe alopecia areata in adults and adolescents aged 12 years and over.

SMC2611 08/04/2024 daridorexant (Quviviq) Full

Treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

SMC2618 08/04/2024 mavacamten (Camzyos) Full

For treatment of symptomatic (New York Heart Association, NYHA, class II III) obstructive hypertrophic cardiomyopathy (HOCM) in adult patients.

SMC2633 08/04/2024 tirzepatide (Mounjaro) Full

For treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

  • in addition to other medicinal products for the treatment of diabetes
SMC2635 08/04/2024 dostarlimab (Jemperli) Full

In combination with platinum-containing chemotherapy (PCC) for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

SMC2650 08/04/2024 mirikizumab (Omvoh) Abbreviated

For treatment of adults with moderately to severely active ulcerative colitis who are intolerant of, or whose disease has had an inadequate response or loss of response to, either conventional therapy or a biologic or have medical contraindications to such therapies.

SMC2652 08/04/2024 glycopyrronium/formoterol fumarate (Bevespi Aerosphere) Abbreviated

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

SMC2557 13/03/2024 nirmatrelvir and ritonavir (Paxlovid) Collaboration

Treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19

SMC2574 11/03/2024 foslevodopa-foscarbidopa (Produodopa) Abbreviated

Treatment of advanced levodopa-responsive Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

SMC2607 11/03/2024 talazoparib (Talzenna) Full

As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

SMC2617 11/03/2024 olaparib (Lynparza) Full

In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

SMC2615 11/03/2024 ivosidenib (Tibsovo) Full

In combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.

SMC2628 11/03/2024 axicabtagene ciloleucel (Yescarta) Full

Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

SMC2662 11/03/2024 pitolisant (Wakix) Non submission

To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).

SMC2663 11/03/2024 satralizumab (Enspryng) Non submission

As a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

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Publication due date SMC meeting date Medicine Submission Type Indication
10/06/2024 estrasimod (Velsipity Abbreviated

For the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

10/06/2024 07/05/2024 glofitamab (Columvi) Full

As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

10/06/2024 07/05/2024 epcoritamab (Tepkinly) Full

As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy

10/06/2024 07/05/2024 voxelotor (Oxbryta) Full

Treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide

10/06/2024 07/05/2024 tirzepatide (Mounjaro) Full

For weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial body mass index (BMI) of:

  • ≥30 kg/m2 (obesity), or

  • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea [OSA], cardiovascular disease [CVD], prediabetes, or type 2 diabetes mellitus [T2DM])
10/06/2024 TBC momelotinib (Omjjara) Abbreviated

The treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

08/07/2024 04/06/2024 empagliflozin (Jardiance) Full

In adults for the treatment of chronic kidney disease.

08/07/2024 04/06/2024 relatlimab / nivolumab (Opdualag) Full

For treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and over.

08/07/2024 04/06/2024 birch bark extract (Filsuvez) Ultra-orphan initial assessment

For treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged 6 months and older.

08/07/2024 TBC pembrolizumab (Keytruda) Full

in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

08/07/2024 TBC pegunigalsidase alfa (Elfabrio) Resubmission

Long-term enzyme replacement therapy (ERT) in adult patients with confirmed diagnosis of Fabry disease (FD) (deficiency of alpha galactosidase).

12/08/2024 02/07/2024 etranacogene dezaparvovec (Hemgenix) Full

For treatment of severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.

12/08/2024 02/07/2024 trifluridine tipiracil (Lonsurf) Full

In combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.

09/09/2024 06/08/2024 rezafungin acetate (Rezzayo) Full

For the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.

TBC 10/01/2023 levodopa/carbidopa/entacapone (Lecigon) Full

For treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results

TBC 07/02/2023 tebentafusp (Kimmtrak) Full

as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

TBC TBC fosdenopterin (Nulibry) Ultra-orphan initial assessment

Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

TBC 02/04/2024 linzagolix (Yselty) Full

For treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

TBC TBC voretigene neparvovec (Luxturna) Ultra-orphan reassessment

For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

TBC TBC pembrolizumab (Keytruda) Full

In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

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