Stelara: Johnson and Johnson’s received FDA approval for Stelara to treat adolescents aged 12 and older with moderate to severe plaque psoriasis. The data received by the FDA from phase 3 showed at least two-third of the patients receiving Stelara had improved to clear or minimal psoriasis by week 12 of treatment.
Tacforius: The Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation to Teva B.V for Tacforius for Prophylaxis of transplant rejection in adult kidney or liver allograft recipients, and Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.
The active substance of Tacforius is tacrolimus, a macrolide immunosuppressant medicinal product that inhibits the activation of the serine-threonine phosphatase, calcineurin, in T lymphocytes. This suppresses T lymphocyte activation and the subsequent generation of cytotoxic lymphocytes, thereby down regulating processes leading to acute graft rejection. T-helper cell-dependent B cell proliferation is also affected.
Tacforius will be available as prolonged-release capsules (0.5 mg, 1 mg, 3 mg and 5 mg).
Cabometyx: Ipsen announced that its Phase 3 clinical trial involving Cabometyx (cabozantinib) for the treatment of advanced liver cancer has shown better overall survival benefits compared to placebo. The once daily drug therefore has the potential to bring a new oral systemic treatment to previously treated patients with advanced liver cancer.
USFDA has approved this drug to treat advanced Renal Cell Carcinoma in patients who have received prior anti-angiogenic therapy.
European regulators had already approved to treat advanced renal cell carcinoma in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Could be first vaccination against Ebola
A report in the New England Journal of Medicine mentioned about a Phase 2 study involving 1,500 people in Monrovia and Liberia. Participants were randomly assigned to receive one of two vaccines being tested, or a placebo. two vaccine candidates a large-scale effort to test what could be the first vaccine against Ebola.
The vaccine candidates included rVSV-ZEBOV and cAd3-EBOZ
After one month, 84 percent of rVSV-ZEBOV recipients developed an antibody response with persisted protection in 80 percent at one year.
Of the subjects in cAd3-EBOZ trial, 71 percent developed an antibody response which persisted in 64 percent at one year.
Overall, investigators did not identify any major safety concerns related to the vaccines. Most of the serious medical issues reported during the trial were due to malaria.
The CHMP recommended a change to the terms of Roche Registration Limited’s marketing authorisation for Alecensa.
CHMP adopted an extension to the existing indication from “Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)” to “Alecensa as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib”.
In addition, since all specific obligations of the conditional marketing authorisation have been fulfilled, the marketing authorisation for Alecensa will be switched from conditional to full approval.
The CHMP adopted a change to the existing indication to extend the use of Bydureon in combination with insulin. Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products, including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control.
The CHMP recommended a change to the terms of Merck Sharp & Dohme Limited’s marketing authorisation for the medicinal product Cubicin.
Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Cubicin should be coadministered with appropriate antibacterial agent(s).
The extension to existing indication included: Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with right-sided infective endocarditis or with complicated skin and soft-tissue infections (cSSTI), while in paediatric patients, use in bacteraemia should be associated with cSSTI.
The CHMP recommended a change to the terms of AstraZeneca UK Ltd’s marketing authorisation for Faslodex.
The extension to existing new indication included using as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women, not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy and in combination with palbociclib for the treatment of hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
Pegasys (peginterferon alfa-2a):
The CHMP recommended a change to the terms of Roche Registration Limited’s marketing authorisation for Pegasys.
The extension to existing indication included Pegasys for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.
Zytiga (abiraterone acetate):
The CHMP recommended a change to the terms of Janssen-Cilag International NV’s marketing authorisation for Zytiga.
“Zytiga is indicated with prednisone or prednisolone for
1. the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT)
2. the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
3. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.”