Tuesday, Feb 13, 2018

FDA Grants Priority Review for Genentech’s Rituxan (Rituximab) for Pemphigus Vulgaris

• Pemphigus vulgaris (PV) is a life-threatening, autoimmune condition with limited treatment options¹
• The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation for Rituxan in PV

South San Francisco, CA -- February 13, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) and granted Priority Review for the use of Rituxan^® (rituximab) for the treatment of pemphigus vulgaris (PV), a rare, life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.¹

The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to Rituxan for the treatment of PV. Presently, there are limited approved treatment options available for patients with PV.¹

“We are committed to developing medicines for rare diseases with limited treatment options, such as pemphigus vulgaris,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to continued work with the FDA to hopefully provide patients with a new treatment for this serious and potentially life-threatening disease.”

The sBLA submission is based on data from a Roche-supported randomized trial conducted in France which evaluated Rituxan plus a tapering regimen of low dose oral corticosteroid (CS) treatment compared to a standard dose of CS alone as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.² Results of the study show that Rituxan provides substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.² These results were published in The Lancet in March 2017. Genentech is currently conducting another Phase III study in PV which is evaluating Rituxan plus a tapering regimen of CS compared to Cellcept (PEMPHIX, NCT02383589).³ 

About Pemphigus Vulgaris

Pemphigus vulgaris is an autoimmune, intraepidermal, blistering disease affecting the skin and mucous membranes.¹ This rare, life-threatening condition is the most common type of a group of autoimmune disorders collectively called pemphigus, which affect 30,000 to 40,000 people in the United States.⁴
What does Rituxan treat?

Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.

Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Important Side Effect Information

What is the most important information patients should know about Rituxan?

Rituxan can cause serious side effects that can lead to death, including:

• Infusion Reactions: Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during an infusion or within 24 hours after an infusion
• Severe Skin and Mouth Reactions: painful sores or ulcers on skin, lips, or in the mouth; blisters, peeling skin, rash, or pustules
• Hepatitis B Virus (HBV) Reactivation: If a patient has had hepatitis B or is a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again
• Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus

What are the possible side effects of Rituxan?

Rituxan can cause serious and life‐threatening side effects, including:

• Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm
• Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death
• Heart Problems: Rituxan may cause chest pain and irregular heartbeats, which may need treatment, or a patient’s doctor may decide to stop treatment with Rituxan
• Kidney Problems: especially if a patient is receiving Rituxan for non-Hodgkin’s lymphoma (NHL). Doctors should do blood tests to check how well a patient’s kidneys are working
• Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Patients should inform their doctor right away if they have any stomach area pain during treatment with Rituxan
• Low Blood Cell Counts: A doctor may do blood tests during treatment with Rituxan to check a patient’s blood cell counts

What are common side effects during treatment with Rituxan?

• Infusion reactions
• Chills
• Infections
• Body aches
• Tiredness
• Low white blood cell counts

Other side effects include:

• Aching joints during or within hours of receiving an infusion
• More frequent upper respiratory tract infections

Patients should tell their doctor about any side effect that bothers them or does not go away.

These are not all of the possible side effects with Rituxan. For more information, ask a doctor or pharmacist.

Contact a doctor for medical advice about side effects. Report side effects to the FDA at (800) FDA ‐ 1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835 ‐ 2555.

Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information at http://www.rituxan.com.

Genentech and Biogen collaborate on Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

References

¹ Medscape. Pemphigus Vulgaris. Available at: http://emedicine.medscape.com/article/1064187-overview . [Last accessed: January 24, 2018]

² Joly P, et al. First-Line Rituximab Combined with Short-Term Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-Label Randomised Trial. The Lancet. March 22, 2017

³ ClinicalTrials.gov. A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris. Available at: https://clinicaltrials.gov/ct2/show/NCT02383589?term=pemphigus+vulgaris&recr=Open&rank=2. [Last accessed: January 24, 2018]

⁴ International Pemphigus & Pemphigoid Foundation. Pemphigus. Available at: http://www.pemphigus.org/research/clinically-speaking/pemphigus/. [Last accessed: January 24, 2018]

 

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