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Pfizer closes on EU approval of lung cancer drug Vizimpro

And AZ claims first with Forxiga in T1 diabetes


Among the clutch of decisions at the last CHMP meeting was a recommendation for approval of Pfizer’s Vizimpro, an EGFR-targeting drug that could challenge AstraZeneca’s Tagrisso in lung cancer.

The EMA’s advisory committee gave a positive opinion on Vizimpro (dacomitinib) as a single-agent therapy for locally advanced or metastatic EGFR-positive non-small cell lung cancer (NSCLC), setting up a full EMA approval in the coming weeks.

The green light comes after the US FDA approved Vizimpro last September after a considerable delay to the programme caused by the two phase 3 trials in 2014. Pfizer persisted with a third study that showed Vizimpro was able to extend progression-free survival (PFS) compared to AZ’s first-generation EGFR inhibitor Iressa (gefitinib).

Vizimpro will now be able to compete directly with Iressa, Roche’s first-generation EGFR Tarceva (erlotinib) and newer drugs in the class such as Boehringer Ingelheim’s Giotrif (afatinib), although its main rival will be AZ’s Tagrisso (osimertinib). The latter drug already dominates second-line treatment of EGFR-positive NSCLC and AZ has been pushing into the first-line setting.

The CHMP also backed Teva’s CGRP inhibitor Ajovy (fremanezumab) for migraine prevention, setting the drug on course to compete with earlier approvals Aimovig (erenumab) from Amgen/Novartis and Emgality (galcanezumab) from Eli Lilly, as well as biosimilars of AbbVie’s blockbuster anti-TNF drug Humira (adalimumab) for inflammatory and autoimmune diseases from Fresenius Kabi  called Idacio and Kromeya.

The two new biosimilars will join products from Amgen, Samsung Bioepis/Biogen, Mylan/Fujifilm Kyowa Kirin, and Novartis’ Sandoz unit in an assault on AbbVie’s market share for the world’s best-selling drug, which approached $20bn in sales last year. In its fourth-quarter results, AbbVie revealed a sharp decline in non-US revenues for the drug attributed mainly to biosimilar competition in Europe.

AZ claims first with Forxiga in type 1 diabetes


Among the usual crop of line extensions, AZ’s SGLT2 inhibitor Forxiga (dapagliflozin) became the first oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes, adding to its use in type 2 diabetes. The drug is also under regulatory review for this indication in the US and Japan, and the new use could help AZ compete in the market with SGLT2 rivals Invokana (canagliflozin) from Janssen and Boehringer Ingelheim/Lilly’s Jardiance (empagliflozin).

Roche claimed a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in adults and children with severe haemophilia A without factor VIII inhibitors, greatly extending the number if patients eligible for the drug in Europe and setting it further on course for what some analysts predict could be $2bn in peak sales.

Merck & Co/MSD added to its growing collection of approvals for cancer immunotherapy Keytruda (pembrolizumab) with a green light as a first-line treatment for metastatic squamous NSCLC in combination with paclitaxel or nab-paclitaxel chemotherapy, while Roche’s rival Tecentriq (atezolizumab) was recommended for adults with locally-advanced or metastatic bladder cancer , specifically after prior platinum-containing chemotherapy, or in patients considered cisplatin ineligible, and whose tumours have a PD-L1 expression of 5% or more.

Meanwhile, Sanofi picked up new labelling for cholesterol-lowering antibody Praluent (alirocumab) that included a cardiovascular risk reduction claim, while Roche’s venerable antibody drug MabThera (rituximab) added the new indication of moderate to severe pemphigus vulgaris (PV), an autoimmune blistering disease.

Bristol-Myers Squibb’s Orencia (abatacept) was backed as a second-line treatment for moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients (2 years and older), and AbbVie’s Maviret (glecaprevir/pibrentasvir) got the nod for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 and above.

There was bad news for TLC Biopharmaceuticals however after the CHMP rejected its marketing application for Doxolipad, a pegylated liposomal formulation of doxorubicin intended for breast and ovarian cancer, which had been developed as an alternative to Janssen-Cilag’s Caelyx. The panel concluded that TLC hadn’t proved that the two drugs were equivalent.

Article by
Phil Taylor

4th February 2019

From: Regulatory



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