Pfizer gets FDA nod for second Remicade biosimilar
The Food and Drug Administration recently approved Pfizer’s Ixifi (infliximab-qbtx), the company’s second approved biosimilar of Janssen’s Remicade. The biosimilar was approved for all of Remicade’s indications, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and plaque psoriasis, among others.
The approval follows the April 2016 launch of its first Remicade biosimilar Inflectra. According to reports, Pfizer has said it has no plans to launch Ixifi in the United States.
Outside the United States, Pfizer markets Inflectra, Retacrit (epoetin zeta) and Nivestim (filgrastim). It said that its biosimilars pipeline includes 13 distinct biosimilar molecules in various stages of development.
Teva’s generic Viread launches
Tevs has introduced its exclusive generic of Gilead’s Viread (tenofovir disoproxil fumarate), the company announced Friday. The drug is indicated to treat HIVE in adults and pediatric patients ages 2 years old and older, as well as chronic hepatitis B in patients ages 12 years old and older.
“Currently, 1.1 million people in the U.S are living with HIV and an estimated 850,000 to 2.2 million have chronic hepatitis B virus infection,” Teva executive vice president of North America commercial Brendan O’Grady said. “The launch of generic Viread is an important addition to our portfolio; but, more importantly, it brings an effective, affordable treatment option to these patients in an area that’s lacking.”
Teva’s generic will be available in 300-mg dosage strength tablets. The product had U.S. sales of roughly $762 million for the 12 months ended October 2017, according to IQVIA data.
Two moms come together to form the Meningitis B Action Project
The Meningitis B Action Project launched earlier this month with a cross-country campaign initiated by two mothers who each lost their young, healthy daughters to Meningitis B five years ago. The Project aims to provide parents and young adults with the information to proactively talk to their healthcare provider about Meningitis B and the vaccine available to help prevent it, and to encourage the medical and education community to inform patients and students about the availability of the Meningitis B vaccine.
“I lost my 17-year-old daughter Kimberly to Meningitis B in 2012, two years before Meningitis B vaccines became available in the U.S. When the doctor in the Emergency Room told me she suspected my daughter had bacterial meningitis, I told the doctor it wasn't possible because she had been vaccinated against meningitis,” shared Pattie Wukovits, a registered nurse. “But what I didn't know, and what so many parents still don't realize, is that there is a separate strain of meningococcal disease – MenB – that is not covered by the traditional, more widely-known meningitis vaccine.”
The Project is a joint initiative by Wukovits and Alicia Stillman who each lost their daughters to Meningitis B. High school senior Kimberly Coffey, 17, died a few days before her graduation. College sophomore Emily Stillman, 19, died just 36 hours after her first symptoms. While both had received the MenACWY vaccine, the MenB vaccine was not yet available to help protect them. In 2014, Wukovits and Stillman, an accountant, established their own foundations named after their daughters, The Kimberly Coffey Foundation and The Emily Stillman Foundation. Today, both mothers are joining forces to make sure other parents don’t needlessly suffer the same fate.
Meningococcal disease, one of the most common types of bacterial meningitis, is a life-threatening bacterial infection caused by five types of meningococcal bacteria – A, B, C, W and Y. It affects all ages, but is more common among 16-23 year olds. Meningitis B accounts for nearly 50% of all meningococcal disease cases among 17-22 year olds in the U.S., and 100% of all meningococcal disease outbreaks on college campuses in the U.S. since 2011. As many as 44 college campuses have reported cases of meningococcal disease since 2013.
Two separate vaccines, MenACWY and MenB, are necessary to be fully immunized against the disease. The MenACWY vaccine is recommended for 11-12 year olds, with a booster shot at 16. The MenB vaccine is suggested for 16-23 year olds, preferably at 16 through 18 years old, and only recently became available in the U.S. in late 2014. However, while most adolescents and young adults have received the MenACWY vaccine, few have received the MenB vaccine largely due to lack of awareness of its availability.
“If I didn’t know, I’m sure other people don’t know. I said to her that day, I’m going to figure this out. By educating both parents and students on Meningitis B, its symptoms, and the vaccine to help stop it, we have the ability to save other young people from this deadly, but preventable disease,” said Stillman.
As part of the Project, Wukovits and Stillman will travel the country to share their stories across communities, schools and college campuses. Educational resources and tools, including a full action kit, and educational brochure, posters, and shareable videos and graphics, are available for download on the Project’s website to help individuals and organizations spread the word.
“We realize that if we want everyone to hear this critical message about Meningitis B, we can’t do it alone. Through the Meningitis B Action Project, our hope is that we will be able to build an army of advocates to help us spread our message as broadly as possible,” said Wukovits.