Relapsing Fever

THURSDAY, July 20, 2023 -- During 2012 to 2021, 251 cases of soft tick relapsing fever (STRF), caused by certain Borrelia spirochetes and transmitted to humans by soft-bodied Ornithodoros ticks, were reported in 11 states, according to research published in the July 21 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report . Amy M. Beeson, M.D., from the CDC in Atlanta, and colleagues summarized demographic and clinical information for STRF cases reported during 2012 to 2021. The researchers identified 251 cases in 11 states during the study period, with a median annual case count of 24. During the study period, there was no significant change in the number of cases observed. Overall, 55 percent of the patients with STRF were hospitalized, but there were no fatalities. Since the 1990s, the geographic distribution and seasonal pattern of STRF have remained relatively constant. In areas where STRF is endemic, persons should avoid rodent-infested structures and habitats, such as caves. "To reduce STRF incidence in the United States, progress in surveillance, prevention, and disease recognition is needed," the authors write. "Residents and visitors to areas where STRF is endemic should be educated about how to prevent soft tick bites (most importantly, avoidance of rodent-infested structures and rodent habitats such as caves) and when to seek medical care." Abstract/Full Text Posted July 2023

Four new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended four medicines for approval at its November 2022 meeting. The CHMP recommended authorising the COVID-19 vaccine VidPrevtynBeta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below. The committee adopted a positive opinion for a biosimilar medicine , Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break. A generic medicine , Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. The CHMP adopted a positive opinion for a generic medicine , Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant. Recommendations on extensions of therapeutic indication for 11 medicines The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin , Comirnaty , DuoPlavin , Dupixent , Enhertu , Eylea , Imfinzi , Iscover , Lynparza , Plavix and Xofluza . Withdrawals of applications Two applications for marketing authorisation were withdrawn: Orepaxam * for the treatment of pulmonary arterial hypertension, and Febseltiq * for the treatment of cholangiocarcinoma (cancer of the bile ducts). Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes. Question-and-answer documents on the withdrawals are available in the grid below. COVID-19 update The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. Safety update The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee ( PRAC ) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case ofquality, safety or efficacy issues. A public health communication on this referral is available in the grid below. Agenda and minutes The agenda of the November 2022 CHMP meeting is published on EMA's website. Minutes of the October 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the November 2022 CHMP meeting are represented in the graphic below. *This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendation on new medicines Name of medicine VidPrevtyn Beta International non-proprietary name (INN) COVID-19 vaccine (recombinant, adjuvanted) Marketing-authorisation applicant Sanofi Pasteur Therapeutic indication VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral vector COVID-19 vaccine More information VidPrevtyn Beta: Pending EC decision News announcement: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine Positive recommendation on new biosimilar medicine Name of medicine Kauliv INN teriparatide Marketing-authorisation applicant Strides Pharma Cyprus Therapeutic indication Treatment of osteoporosis More information Kauliv: Pending EC decision Positive recommendations on new generic medicines Name of medicine Pirfenidone Viatris INN pirfenidone Marketing-authorisation applicant Viatris Limited Therapeutic indication Treatment of idiopathic pulmonary fibrosis More information Pirfenidone Viatris: Pending EC decision Name of medicine Sugammadex Amomed INN sugammadex Marketing-authorisation applicant AOP Orphan Pharmaceuticals GmbH Therapeutic indication Reversal of neuromuscular blockade induced by rocuronium or vecuronium More information Sugammadex Amomed: Pending EC decision Positive recommendations on extensions of indications Name of medicine Ceprotin INN human protein C Marketing-authorisation holder Takeda Manufacturing Austria AG More information Ceprotin: Pending EC decision Name of medicine Comirnaty INN tozinameran Marketing-authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: Pending EC decision Name of medicine DuoPlavin INN clopidogrel / acetylsalicylic acid Marketing-authorisationholder Sanofi-aventis groupe More information DuoPlavin: Pending EC decision Name of medicine Dupixent INN dupilumab Marketing-authorisation holder Sanofi-aventis groupe More information Dupixent: Pending EC decision Name of medicine Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: Pending EC decision Name of medicine Eylea INN aflibercept Marketing-authorisation holder Bayer AG More information Eylea: Pending EC decision Name of medicine Imfinzi INN durvalumab Marketing-authorisation holder AstraZeneca AB More information Imfinzi: Pending EC decision Name of medicine Iscover INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Iscover: Pending EC decision Name of medicine Lynparza INN olaparib Marketing-authorisationholder AstraZeneca AB More information Lynparza: Pending EC decision Name of medicine Plavix INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Plavix: Pending EC decision Name of medicine Xofluza INN baloxavir marboxil Marketing-authorisationholder Roche Registration GmbH More information Xofluza: Pending EC decision Withdrawal of initial marketing authorisation application Name of medicine Febseltiq INN infigratinib Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Limited More information Febseltiq: Withdrawn application Name of medicine Orepaxam INN treprostinil diolamine Marketing-authorisationapplicant Ferrer Internacional S.A. More information Orepaxam: Withdrawn application Withdrawals of post-authorisation marketing authorisation applications Name of medicine Gavreto INN pralsetinib More information Gavreto: Withdrawn application Name of medicine Ilaris INN canakinumab More information Ilaris: Withdrawn application Conclusion of referral Name of medicine Janus kinase (JAK) inhibitors More information Janus Kinase inhibitors (JAKi) Other updates List item Scientific advice and protocol assistance adopted during the CHMP meeting 7-10 November 2022 (PDF/246.92 KB) (new) Adopted First published: 11/11/2022 EMA/CHMP/SAWP/872304/2022 List item Start of Union reviews adopted during the CHMP meeting of 7-10 November 2022 (PDF/106.5 KB) (new) Adopted First published: 11/11/2022 EMA/846051/2022

Bachelor Nation's Kelley Flanagan reveals how finally receiving a tick-borne disease diagnosis through IGeneX Lab changed her life for the better MILPITAS, Calif., June 8, 2022 /PRNewswire/ -- Like hundreds of thousands of Americans, Kelley Flanagan developed mysterious health symptoms with, seemingly, no answers, that began in fourth grade but increased after her season of The Bachelor. After a diagnosis of Lyme Disease in 2021 via IGeneX Lab, she joined the over 300,000 (Bay Area Lyme Foundation) new patients each year that contract Lyme Disease, and began to discover just how deeply tick-borne disease can affect each facet of your life. Further, without effective diagnosis and treatment, symptoms can often worsen and progress into severe and even life-threatening health issues. "[My brother] started doing so much evidence-based research, whether it was reading books, podcasts, documentaries… anything he could find that pertained to Lyme disease. That's when he figured out that [he] most likely had Lyme disease. [My brother] was the one to say, 'I think you have Lyme.' After I came back from the show, I just knew something was wrong. It was around 4th grade when I noticed something was wrong- my digestion was off. It actually took my brother, Tom, to figure out that he had Lyme… because he goes hunting and got bit by a tick," Flanagan told IGeneX recently. "Flanagan recently told IGeneX that mindset is key in her health journey..." Tweet this Speaking with IGeneX in May of 2022 during Lyme Disease Awareness Month, Flanagan opened up about why she chose to be tested for Lyme with IGeneX: "The test that I found was the most accurate when I was doing all my research was, IGeneX. When it came to me getting tested, there were essentially no other options. I knew what was out there… IGeneX is the best on the market." IGeneX prides itself on testing for not only more relevant strains of tick-borne pathogens than any other lab, but even for pathogens that exhibit Lyme-like symptoms but arise from a different tick-borne disease. These often require different treatment paths- like common co-infections Babesiosis, Bartonella and Relapsing Fever. Fortunately, IGeneX's ImmunoBlot boasts a sensitivity rate that is nearly double that of the standard two-tier testing protocol. Flanagan has been on the up and up since her initial diagnosis in 2021. Flanagan recently told IGeneX that mindset is key in her health journey: "I knew I was in a space where my body wasn't doing well. I know that it gets a little bit hectic to talk about it [Lyme Disease] constantly and that is something that I struggle with. Mindset is a huge thing for me and I want to focus on being a little bit more healthy instead of focusing on the downfalls." "Without accurate, multi-species tests that detect infection at all stages of disease, patients are unable to receive a correct diagnosis and cannot begin to get better. I speak for the entire IGeneX team when I say that we are grateful for Kelley's continued advocacy around accurate tick-borne illness testing," said Dr. Jyotsna Shah, PhD, President and Laboratory Director of IGeneX. Founded in 1991, IGeneX is at the forefront of Lyme and tick-borne disease research. The two-tier ELISA/Western Blot testing recommended by the CDC uses outdated result criteria developed in 1994, leading to many missed infections and preventable suffering. In contrast, the IGeneX ImmunoBlot, which detects eight strains of Borrelia, produces a higher sensitivity, and remains the most comprehensive testing for Lyme disease antibodies. Press contact: Alex moresco [email protected] For more information on how to order IGeneX Lyme and tick-borne disease testing, please contact IGeneX today at 1-800-832-3200 or visit igenex.com. SOURCE IGeneX