Roche Holding AG’s (RHHBY - Free Report) subsidiary, Genentech, announced that the FDA has accepted its supplemental biologics license application (sBLA) and granted Priority Review status to Rituxan (rituximab) in children with two rare blood vessel disorders. The sBLA is for the use of Rituxan in combination with glucocorticoids (GCC) for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children aged two years or older.
Notably, Priority Review designation is granted to drugs that have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.
The sBLA was submitted based on data from the PePRS study, a phase IIa, single-arm study investigating the safety, pharmacodynamics/pharmacokinetics and exploratory efficacy of intravenous Rituxan in 25 patients with severe GPA or MPA between six and 17 years of age. The PePRS study is the first global trial of the drug in pediatric patients with GPA or MPA. If approved, this would be the first pediatric indication for the drug.
Rituxan is currently approved for the treatment of four autoimmune indications. The FDA approved the drug for rheumatoid arthritis (RA) in 2006, GPA and MPA in 2011, and pemphigus vulgaris in 2018.
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.
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 12.0% in year to date compared with the industry's growth of 5.3%.
The company’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 & Stock to Consider
Roche currently carries a Zacks Rank #2 (Buy).
A better-ranked stock worth considering is Bristol-Myers Squibb Company (BMY - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates increased from $4.79 to $5.03 for 2020 over the past 60 days. Estimates for 2020 also increased 48 cents. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 11.85%.
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