CHMP backs one generic and six label extensions

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended just one generic medicine for approval at its October meeting.

The group is backing Teva’s Tacforius (tacrolimus) - a generic of Astellas' Advagraf - as an option to prevent and treat transplant rejection, after it demonstrated bioequivalence to its reference product in clinical studies.

The drug is a macrolide immunosuppressant that inhibits the activation of the serine-threonine phosphatase, calcineurin, in T lymphocytes, suppressing T lymphocyte activation and the subsequent generation of cytotoxic lymphocytes, and so down regulating processes leading to acute graft rejection.

The Committee has also recommended extensions of indications for Roche’s Alecensa (alectinib), AstraZeneca’s Bydureon (exentide), MSD’s Cubicin (daptomycin), AZ’ Faslodex (fulvestrant), Roche’s Pegasys (peginterferon alfa-2a) and Janssen-Cilag’s Zytiga (abiraterone).

Alecensa was recommended as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).

The drug was also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.

Elsewhere, the CHMP adopted a change to Bydureon’s existing indication to extend its in combination with insulin, which would significantly wide the drug’s scope.

For Cubicin, the group is recommending expanding the indication to include paediatric (one to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB) and that, in adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.

Faslodex was backed as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women in certain circumstances, or 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.

The Committee also backed expanding the scope of Pegasys to include the treatment of HBeAg-positive chronic hepatitis B in non-cirrhotic children and adolescents three years of age and older with evidence of viral replication and persistently elevated serum ALT levels.

Finally, expansion of Zytiga’s (abiraterone acetate) reach in patients with prostate cancer was recommended, to include its use alongside prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer in adult men in combination with androgen deprivation therapy.