The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use have brought some good news for Pfizer/Bristol-Myers Squibb’s new blood thinner while the safety of Takeda’s diabetes drug Actos is being reviewed.
First up, the CHMP has recommended approval of B-MS/Pfizer’s Eliquis (apixaban) for the prevention of venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery. The drug targets the Factor Xa protein and if approved will compete with other new anti-clotting treatments such as Bayer’s Xarelto (rivaroxaban) and Boehringer Ingelheim’s Pradaxa (dabigatran).
The CHMP has also issued positive opinions for Yellox (bromfenac) from Croma-Pharma for the treatment of postoperative ocular inflammation following cataract extraction and the oral contraceptives Zoely and IOA (nomegestrol acetate/estradiol) from Merck Serono and Merck & Co unit Organon.
The committee also recommended ViroPharma’s Cinryze (C1 inhibitor [human]) for angioedema attacks but noted that the company is considered the same applicant as Sanquin, which holds marketing authorisations in some European Union states “for a medicine with the same composition and pharmaceutical form and overlapping indications”. This may preclude the granting of a thumbs-up for Cinryze.
The CHMP has also backed extensions to the label of Roche’s Herceptin (trastuzumab) in breast cancer , Novartis’ eye drug Lucentis (ranibizumab), Johnson & Johnson’s Remicade (infliximab) in Crohn’s disease and Pfizer’s Revatio (sildenafil) for pulmonary arterial hypertension.
No to Vectibix extension, Genzyme Thyrogen shortage
There was worse news for Amgen after the committee adopted a negative opinion for Vectibix (panitumumab), saying that the current indication should not be extended to include its use in combination with chemotherapy in patients with wild-type KRAS metastatic carcinoma of the colon or rectum. An appeal from the US biotech could be in the offing as the US biotech said it will “consider appropriate next steps”, as it believes Vectibix in combination with chemotherapy provides an important treatment option for the aforementioned patients.
Meantime, the CHMP added that it has been informed by Genzyme about shortages until July of its thyroid drug Thyrogen (thyrotropin alfa) due to a manufacturing issue. The company, which is in the process of being bought by Sanofi-Aventis, will only be able to supply Thyrogen to meet 45% of EU demand.
Meantime, the agency has begun looking at the benefit-risk balance of Takeda’s Actos (pioglitazone) and its other pioglitazone-containing medicines “to further explore the signal of a possible increased risk of bladder cancer with pioglitazone”. It noted that a link has been under close reviewsince the granting of the first marketing authorisation in 2000 and three interim study reports have so far not confirmed a clear association.
However, “prompted by an increased number of spontaneous reports of bladder cancer”, the committee considered that “the accumulated evidence provided also by preclinical studies, epidemiological data and the PROactive trial, taken in its totality, represents a clinically relevant signal which requires further evaluation”.
A probe is also underway for Celgene’s multiple myeloma drug Revlimid (lenalidomide) following reports indicating that the treatment may be associated with an increased risk of second primary malignancies.
