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SMC ID Date Medicine Submission Type Indication
SMC2340 08/02/2021 apremilast (Otezla) Non submission

Treatment of adult patients with oral ulcers associated with Behçet’s disease who are candidates for systemic therapy.

SMC2341 08/02/2021 glasdegib (Daurismo) Non submission

In combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.

SMC2339 08/02/2021 alpelisib (Piqray) Non submission

In combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

SMC2344 08/02/2021 omalizumab (Xolair) Non submission

As add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps for whom therapy with INC does not provide adequate disease control.

SMC2343 08/02/2021 mercaptamine (Cystadrops) Non submission

Treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

SMC2316 08/02/2021 buprenorphine/naloxone (Suboxone) Abbreviated

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction.

SMC2320 08/02/2021 leuprorelin acetate (Prostap DCS) Abbreviated

As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.

SMC2319 08/02/2021 leuprorelin acetate (Prostap DCS) Abbreviated

As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement). In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy.

SMC2309 08/02/2021 ozanimod (Zeposia) Full

For adult patients with relapsing remitting multiple sclerosis.

SMC2305 08/02/2021 ravulizumab (Ultomiris) Full

For the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH):
• in patients with haemolysis with clinical symptom(s) indicative of high disease activity
• in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months.

SMC2315 08/02/2021 upadacitinib (Rinvoq) Full

For treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

SMC2342 08/02/2021 imipenem/cilastatin/relabactam (Recarbrio) Non submission

Indication under review: For the treatment of:

  • hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults
  • bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.
1251/17 08/02/2021 afamelanotide (Scenesse) Full

for prevention of photoxicity in adult patients with erythropoietic protoporphyria (EPP). Scenesse is to be administered under a Post-Authorisation Safety Study (PASS) protocol in line with the approved European Medicines Agency Risk Management Plan.

SMC2321 08/02/2021 formoterol fumarate dihydrate/glycopyrronium/budesonide (Trixeo Aerosphere) Abbreviated

Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long‑acting beta2‑agonist or combination of a long-acting beta2‑agonist and a long‑acting muscarinic antagonist.

SMC2323 18/01/2021 apalutamide (Erleada) Non submission

In adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

SMC2325 18/01/2021 talazoparib (Talzenna) Non submission

As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer.

SMC2324 18/01/2021 dupilumab (Dupixent) Non submission

As an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

SMC2308 18/01/2021 secukinumab (Cosentyx) Full

For the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

SMC2326 18/01/2021 daratumumab (Darzalex) Abbreviated

In combination with bortezomib, thalidomide and dexamethasone is indicated for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

SMC2306 18/01/2021 melatonin (Slenyto) Resubmission

For the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

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Publication due date SMC meeting date Medicine Submission Type Indication
08/03/2021 02/02/2021 entrectinib (Rozlytrek) Full

For the treatment of adult and paediatric patients 12 years of age and older, with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion:

  • who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
  • who have not received a prior NTRK inhibitor
  • who have no satisfactory treatment options
08/03/2021 beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

08/03/2021 trametinib (Mekinist) Abbreviated

For treatment in combination with dabrafenib (Tafinlar) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. This is an abbreviated submission to remove the SMC restriction to first-line treatment.

08/03/2021 doravirine (Pifeltro) Abbreviated

In combination with other antiretroviral medicinal products, for the treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.

08/03/2021 doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) Abbreviated

For the treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, lamivudine, or tenofovir.

08/03/2021 02/02/2021 onasemnogene abeparvovec (Zolgensma) Full

For the treatment of:

  • patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene and a clinical diagnosis of SMA type 1, or
  • patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene
12/04/2021 02/03/2021 dupilumab (Dupixent) Full

In adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

12/04/2021 02/03/2021 ataluren (Translarna)

Treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older.

12/04/2021 dapagliflozin (Forxiga) Full

In adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

12/04/2021 galcanezumab (Emgality) Full

Prophylaxis of migraine in adults who have at least 4 migraine days per month

12/04/2021 02/03/2021 isatuximab (Sarclisa) Full

In combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

10/05/2021 06/04/2021 encorafenib (Braftovi) Full

In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.

14/06/2021 04/05/2021 baricitinib (Olumiant) Full

Treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

14/06/2021 04/05/2021 acalabrutinib (Calquence) Full

As monotherapy or in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)

Q2 2021 Q2 2021 chlormethine hydrochloride (Ledaga) Full

Topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Q2 2021 Q2 2021 ravulizumab (Ultomiris) Full

Treatment of patients with a body weight of 10kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Q2 2021 Q2 2021 trifluridine/tipiracil (Lonsurf) Full

As monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Q2 2021 Q2 2021 nintedanib (Ofev) Full

Treatment in adults of other chronic fibrosing interstitial lung diseases with a progressive phenotype.

Q2 2021 Q2 2021 niraparib (Zejula) Full

As monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

Q2 2021 Q2 2021 mogamulizumab (Poteligeo) Full

For the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

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