Marketing authorisation for trio as reviews begin

 Three new medicines were granted a positive opinion for a marketing authorisation, a series of reviews began, and the CHMP learned of a shortage of Thyrogen (thyrotropin alfa) at its March meeting.

Eliquis (apixaban), Yellox (bromfenac) and Zoely and IOA (nomegestrol acetate/estradiol) were all given the green light by the Committee for marketing authorisations.

Reviews began into antidiabetic pioglitazone-containing medicines, the orphan medicine Revlimid (lenalidomide), Vivaglobin and associated names, and into the results of good clinical practice (GCP) inspection for three products.

Genzyme Europe also informed the CHMP that there would be a shortage of Thyrogen (thyrotropin alfa) until July 2011 due to a manufacturing issue.

Patients were granted additional treatment options after positive opinions for applications for extensions of therapeutic indications were granted for:

· Herceptin (trastuzumab) to include treatment of patients with HER2-positive early breast cancer in combination with adjuvant chemotherapy consisting of paclitaxel or docetaxel following adjuvant chemotherapy with doxorubicin and cyclophosphamide, or consisting of docetaxel and carboplatin.

· Lucentis (ranibizumab) to include treatment of visual impairment due to macular oedema secondary to retinal vein occlusion.

· Remicade (infliximab) to extend the approved indication for severe Crohn’s disease to patients with moderately to severely active disease, and

· Revatio (sildenafil) to include paediatric patients aged one to 17 years with pulmonary arterial hypertension.

AstraZeneca’s Arimidex (anastrozole) was also recommended for the harmonisation of the prescribing information to treat breast cancer in post-menopausal women.

But the news was not so good for Vectibix (panitumumab) after the CHMP recommended its current indication should not be extended for its use with chemotherapy for patients with wild-type KRAS metastatic carcinoma of the colon or rectum.

The CHMP has began analysing the benefit-risk balance of antidiabetic pioglitazone-containing medicines from Takeda Global Research and Development Centre (Europe) to explore a possible increased risk of bladder cancer with pioglitazone.

A similar study into Celgene’s orphan medicine Revlimid (lenalidomide) has started following reports that lenalidomide may be associated with an increased risk of second primary malignancies.