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SMC ID Date Medicine Submission Type Indication
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.

SMC2590 12/02/2024 cabozantinib (Cabometyx) Full

As monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

SMC2592 12/02/2024 secukinumab (Cosentyx) Full

Treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.

SMC2598 12/02/2024 dupilumab (Dupixent) Full

Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

SMC2609 12/02/2024 loncastuximab tesirine (Zynlonta) Full

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

SMC2623 12/02/2024 difelikefalin (Kapruvia) Full

Treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.

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Publication due date SMC meeting date Medicine Submission Type Indication
13/05/2024 02/04/2024 ruxolitinib (Opzelura) Full

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

13/05/2024 TBC budesonide/formoterol (Symbicort) Full

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

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

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 TBC 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

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 empagliflozin (Jardiance) Full

In adults for the treatment of chronic kidney disease.

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.

TBC TBC relatlimab / nivolumab (Opdualag) Full

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

TBC somapacitan (Sogroya) Abbreviated
TBC TBC 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.

TBC TBC 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.

TBC TBC 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.

TBC TBC 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])
TBC TBC 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 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.

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