Meningococcal quadrivalent (serogroups A, C, W135 and Y) tetanus toxoid conjugate vaccine (Nimenrix™).

Nimenrix™ (MenACWY-TT) is a quadrivalent meningococcal conjugate vaccine, comprising the polysaccharide serogroups A, C, W135 and Y, and tetanus toxoid (TT) as carrier protein. It is the first quadrivalent vaccine (administered as a single dose) to be approved in Europe for active immunization of individuals aged ≥ 12 months against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W135 and Y. Administration of a single dose of Nimenrix™ elicited a strong immune response against all four vaccine serogroups in healthy toddlers aged 12-23 months, children and adolescents aged 2-17 years and adults aged 18-55 years in randomized, multicentre, phase III trials.

Mogamulizumab: first global approval.

Mogamulizumab (Poteligeo®) is a defucosylated, humanized monoclonal antibody targeting CC chemokine receptor 4 (CCR4). Development is being carried out by its owner Kyowa Hakko Kirin for various haematological malignancies, and by licensee Amgen for asthma. Mogamulizumab was conceived through Kyowa Hakko Kirin's Potelligent® technology, which produces antibodies with enhanced antibody-dependent cellular cytotoxicity.

Ulipristal acetate: in uterine fibroids.

Ulipristal acetate, a selective progesterone-receptor modulator, inhibits the proliferation and induces apoptosis of leiomyoma cells in vitro. It also modulates the expression of vascular endothelial growth factors and hormone receptors and modulates extracellular matrix breakdown in leiomyoma cells but not in myometrial cells. In two randomized, double-blind, multinational phase III trials of 13 weeks' duration in women aged 18-50 years with uterine fibroids, a once-daily regimen of oral ulipristal acetate 5 mg/day controlled excessive uterine bleeding (primary endpoint) in ≥90% of patients.

Etravirine: a review of its use in the management of treatment-experienced patients with HIV-1 infection.

Etravirine (Intelence®) is an orally administered next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). It is approved for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and are harbouring HIV-1 strains resistant to other antiretroviral (ARV) agents. In the US, etravirine must be used in combination with other ARV agents; in the EU, it must be used in combination with other ARV agents that include a boosted HIV-1 protease inhibitor.

Valsartan: in children and adolescents with hypertension.

Valsartan is an oral angiotensin II subtype 1 receptor antagonist with well established antihypertensive efficacy in adults. It is now approved in the EU and the US for the treatment of hypertension in children and adolescents. In two, randomized, double-blind trials, a once-daily regimen of valsartan reduced the blood pressure (BP) of children and adolescents with hypertension.

Aripiprazole: a review of its use in the management of schizophrenia in adults.

Oral aripiprazole (Abilify®) is an atypical antipsychotic agent that is approved worldwide for use in adult patients with schizophrenia. It is a quinolinone derivative that has a unique receptor binding profile as it exhibits both partial agonist activity at dopamine D(2) receptors and serotonin 5-HT(1A) receptors and antagonist activity at 5-HT(2A) receptors. In several well designed, randomized, clinical trials of 4-6 weeks duration, aripiprazole provided symptomatic control for patients with acute, relapsing schizophrenia or schizoaffective disorder.

Spotlight on ustekinumab in moderate to severe plaque psoriasis.

Ustekinumab (Stelara™) is a human monoclonal antibody that binds to the p40 subunit common to both interleukin (IL)-12 and IL-23. It is indicated in the US for use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In the EU, it is indicated for those who failed to respond to, have a contraindication to, or are intolerant of other systemic therapies or phototherapy.

Ustekinumab: a review of its use in the management of moderate to severe plaque psoriasis.

Ustekinumab (Stelara™) is a human monoclonal antibody that binds to the p40 subunit common to both interleukin (IL)-12 and IL-23. It is indicated in the US for use in adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In the EU, it is indicated for those who failed to respond to, have a contraindication to or are intolerant of other systemic therapies or phototherapy.

Clonidine extended-release: in attention-deficit hyperactivity disorder.

Clonidine, an α(2)-adrenergic agonist, is approved in the US as an extended-release (XR) tablet for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents (aged 6-17 years). In two, randomized, double-blind, multicenter, phase III trials of 8 weeks' duration, clonidine XR improved the symptoms of ADHD in children and adolescents. Significantly greater reductions from baseline in ADHD rating scale IV (ADHD-RS-IV) total scores at week 5 (primary endpoint) were achieved by recipients of clonidine XR 0.

Corifollitropin alfa: a review of its use in controlled ovarian stimulation for assisted reproduction.

Corifollitropin alfa (Elonva®) is a fusion product of human follicle-stimulating hormone (FSH) and the C-terminal peptide of the β-subunit of human chorionic gonadotropin (hCG) produced by recombinant DNA technology. It has the same pharmacologic activity as FSH and recombinant FSH (rFSH; follitropin alfa; follitropin beta), but with a slower absorption and a longer half-life. Corifollitropin alfa is indicated as a multifollicular stimulant for women undergoing controlled ovarian stimulation using gonadotropin-releasing hormone (GnRH) antagonist-assisted reproduction protocols.

Ulipristal acetate: a review of its use in emergency contraception.

Ulipristal acetate (ellaOne®; ella®) is the first of a new class of selective progesterone receptor modulators, and is indicated for emergency contraception within 120 hours after unprotected sexual intercourse or contraceptive failure. The principal effect of ulipristal acetate is to inhibit or delay ovulation. This effect may result from the drug's ability to delay the onset of luteinizing hormone (LH) surge or postpone LH peak if LH surge has started, or possibly by a direct inhibitory effect on follicular rupture, when administered in the follicular phase (including just before ovulation).

Rituximab: as first-line maintenance therapy following rituximab-containing therapy for follicular lymphoma.

Rituximab is a recombinant chimeric murine/human monoclonal IgG(1-κ) antibody. It binds specifically to the CD20 antigen on normal and malignant B lymphocytes and produces complement-dependent and antibody-dependent cytotoxicity and induces apoptosis in these cells. Prolonged treatment with rituximab in patients with follicular lymphoma results in a sustained reduction in circulating B lymphocytes.

Ganciclovir ophthalmic gel 0.15%: in acute herpetic keratitis (dendritic ulcers).

Dendritic epithelial keratitis is most commonly caused by infections of herpes simplex virus (HSV) type 1 (HSV-1), and less frequently by HSV type 2 (HSV-2). Ganciclovir, a guanosine nucleoside analogue, is a well established broad-spectrum antiviral agent that inhibits replication of viral DNA and is active against both HSV-1 and -2 and several other viruses. Ganciclovir ophthalmic gel 0.

Fulvestrant: a review of its use in the management of hormone receptor-positive metastatic breast cancer in postmenopausal women.

Fulvestrant (Faslodex®) is an intramuscularly administered steroidal estrogen receptor antagonist that is devoid of any known estrogen agonist effects. It is indicated as second-line therapy for the treatment of postmenopausal women with hormone receptor-positive advanced breast cancer who have progressed following prior endocrine therapy. In well designed, randomized clinical trials, regimens of fulvestrant 250 and 500 mg provided effective second-line therapy for postmenopausal women with advanced breast cancer who had progressed following prior endocrine therapy.

Trastuzumab: in HER2-positive metastatic gastric cancer.

Trastuzumab is a recombinant humanized IgG₁ monoclonal antibody directed against the extracellular domain of the human epidermal growth factor receptor type 2 (HER2) that inhibits HER2-dependent tumour cell proliferation and survival. Proliferation of gastric cancer cells overexpressing HER2 is inhibited by trastuzumab in vitro and in vivo. HER2-positive expression (defined as immunohistochemistry 3+ or fluorescence in situ hybridization-positive) was observed in 22.

Lidocaine/tetracaine medicated plaster: in minor dermatological and needle puncture procedures.

The lidocaine/tetracaine medicated plaster comprises a lidocaine/tetracaine 70 mg/70 mg patch and a controlled heat-assisted drug delivery pod that increases the diffusion of lidocaine and tetracaine into the dermis. Following a 1-hour application period, systemic absorption of lidocaine or tetracaine from the plaster was minimal. The lidocaine/tetracaine medicated plaster provided effective pain relief for adult (including elderly) patients undergoing minor dermatological procedures and for adult and paediatric patients undergoing vascular access procedures.

Lopinavir/Ritonavir: a review of its use in the management of HIV-1 infection.

Lopinavir/ritonavir (Kaletra®) is an orally administered coformulated ritonavir-boosted protease inhibitor (PI) comprising lopinavir and low-dose ritonavir. It is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, adolescents and children. Lopinavir/ritonavir is available as a tablet, soft-gel capsule and an oral solution for patients with difficulty swallowing.

Dexlansoprazole modified release: in erosive oesophagitis and non-erosive reflux disease.

Dexlansoprazole modified release (dexlansoprazole MR) is an orally administered delayed-release formulation of the R-enantiomer of the proton pump inhibitor lansoprazole that is effective in improving the healing of all grades of erosive oesophagitis, maintaining the healing of erosive oesophagitis and in the treatment of symptomatic non-erosive reflux disease (NERD). In two large, identical, 8-week, randomized, double-blind, multicentre phase III trials, dexlansoprazole MR 60 mg once daily achieved complete healing in >or=92% of patients with all grades of erosive oesophagitis (primary endpoint) and was noninferior to lansoprazole 30 mg once daily using life-table analysis. Moreover, in a randomized, double-blind, multicentre phase III trial in patients with healed erosive oesophagitis, dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing following 6 months' treatment (primary endpoint).

Raltegravir: in treatment-naive patients with HIV-1 infection.

Raltegravir, a first-in-class, oral HIV type-1 (HIV-1) integrase inhibitor, blocks the covalent integration of HIV-1 complementary DNA into the host genome. In a large, randomized, double-blind, multinational, ongoing trial in treatment-naive patients with HIV-1 infection, raltegravir 400 mg twice daily was noninferior to efavirenz 600 mg once daily in achieving plasma HIV-1 RNA viral levels of <50 copies/mL after 48 weeks' treatment (primary endpoint), when used as part of an antiretroviral therapy (ART) combination regimen. The time to achieve a virological response was significantly shorter in the raltegravir group than in the efavirenz group.

Tadalafil: in pulmonary arterial hypertension.

Tadalafil is a selective cyclic guanosine monophosphate-specific phosphodiesterase type 5 inhibitor that is effective in improving exercise ability, the time to clinical worsening and health-related quality of life (HR-QOL) scores in patients with pulmonary arterial hypertension (PAH). In a large, 16-week, randomized, double-blind, placebo-controlled, multicentre, phase III trial (PHIRST) in patients aged >or=14 years with PAH (WHO group I), tadalafil 40 mg once daily (the recommended dosage) significantly increased the mean placebo-corrected 6-minute walk distance (6MWD) by 33 m from baseline (primary endpoint). In treatment-naive patients, tadalafil 40 mg once daily significantly increased the mean placebo-corrected 6MWD by 44 m at week 16, whereas in patients receiving bosentan 125 mg twice daily as background therapy there was a mean change of 23 m, which was not significant.

Olanzapine/fluoxetine: a review of its use in patients with treatment-resistant major depressive disorder.

Olanzapine/fluoxetine (Symbyax) is an oral, once-daily, fixed-dose combination of the atypical antipsychotic olanzapine and the selective serotonin reuptake inhibitor (SSRI) fluoxetine. It is indicated, in adult patients, for the acute treatment of depressive episodes associated with bipolar I disorder and treatment-resistant major depressive disorder. In adult patients with treatment-resistant depression (major depressive disorder in adults who do not respond to two separate trials of different antidepressants of adequate dose and duration in the current episode), olanzapine plus fluoxetine combination therapy was generally more effective than either drug as monotherapy based on an integrated analysis of clinical trials of 8-12 weeks' duration.

Recombinant human thrombin: in surgical hemostasis.

Recombinant human thrombin (rhThrombin) is a serine protease coagulant, manufactured in vitro using recombinant DNA technology, which shares an identical amino acid sequence and similar structure with the native human protein. It is indicated for topical use as an aid to hemostasis in patients undergoing surgery. Topical rhThrombin 1000 U/mL was no less effective than bovine thrombin (bThrombin) 1000 U/mL as a hemostatic agent in a randomized, double-blind, multicenter, phase III trial in patients undergoing various surgical procedures (n = 401).