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Roche Gets Approval for Label Expansion of MabThera in Europe

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Roche Holdings AG (RHHBY - Free Report) announced that the European Commission has approved a label expansion of its rheumatoid arthritis (RA) drug, MabThera.

The drug is now approved in Europe for the treatment of adults with moderate-to-severe pemphigus vulgaris (PV).

Per Roche, MabThera is the first biologic therapy approved by the European Commission for PV.

The FDA had already approved the drug for this indication in June 2018. MabThera is known as Rituxan in the United States.

PV, a rare autoimmune disease characterized by progressive painful blistering of the skin and/or mucous membranes, affects 50,000 people in Europe.

The EU approval was based on positive results form the phase III Ritux study, which evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate-to-severe pemphigus.

As a result of this approval, Rituxan is now approved to treat four autoimmune diseases like RA, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and PV in both the United States and Europe.

We note that MabThera/Rituxan is one of Roche’s legacy drugs. However, the drug is facing biosimilar competition in Europe, which is adversely impacting sales. Sales in 2018 came in at CHF6.7 billion, down 8% from 2017.

Apart from Rituxan, Roche’s rheumatology portfolio has a first-in-class anti-IL-6 receptor therapy, Actemra/RoActemra. The drug is approved for RA, polyarticular and systemic juvenile idiopathic arthritis, giant cell arteritis and chimeric antigen receptor T-cell-induced cytokine release syndrome.

Roche’s stock has gained 13.8% in the past six months compared with the industry's growth of 3%.


Roche’s legacy drugs like Herceptin and MabThera are facing stiff competition from biosimilars.

Novartis (NVS - Free Report) has already launched its biosimilar version of Rituxan/MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin for the treatment of five types of cancers, including lung, colorectal, glioblastoma, renal cell carcinoma and cervix.

Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Celgene Corp. , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Celgene’s earnings per share estimates increased from $10.34 to $10.73 for 2019 over the past 30 days. Estimates for 2020 also increased 48 cents.

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