Farmas USA

MYOV, PFE

Anucio de publicación fase III Liberty en el New England Journal of Medicine. Info conocida

BASEL, Switzerland and NEW YORK, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced publication in the New England Journal of Medicine of the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. As previously reported, both studies achieved the primary endpoint of response rates in menstrual blood loss in addition to six of the seven key secondary endpoints, while maintaining bone mineral density comparable to placebo as part of a well-tolerated safety profile over 24 weeks.

“Women with uterine fibroids often suffer from symptoms such as heavy menstrual bleeding and pain, which can significantly impact their quality of life over many years,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago, and lead author of the publication. “In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo. The data published in the New England Journal of Medicine underscore the potential of relugolix combination therapy to provide an important new treatment option for this common disease.”

LIBERTY 1 and LIBERTY 2 each met the primary endpoint, with 73.4% and 71.2% of women in the relugolix combination therapy groups achieving the responder criteria compared with 18.9% and 14.7% of women in the placebo groups at Week 24, respectively (both p < 0.001). A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline in each study (both p < 0.001 compared to placebo).

“We are pleased that the New England Journal of Medicine recognized the importance of our Phase 3 LIBERTY program and published the study results, which support the potential of once-daily relugolix combination therapy in women with uterine fibroids,” said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. “As we approach our FDA target action date of June 1, we look forward, if approved, to providing a one pill, once-a-day treatment for the millions of women with uterine fibroids who need and deserve new options.”

In LIBERTY 1 and LIBERTY 2, six of seven key secondary endpoints measured at Week 24 achieved statistical significance, including mean reduction in menstrual blood loss, amenorrhea, reduction in pain in women with pain at baseline, improvement on the Bleeding and Pelvic Discomfort scale, reduction in uterine volume (all p < 0.001 compared to placebo), and improvement in anemia in those women with anemia at baseline (both p < 0.05 compared to placebo). In addition, among the approximately 50% of women with moderate-to-severe pain at baseline, a significantly greater proportion of women receiving relugolix combination therapy reported minimal-to-no pain (maximum score of 1 on a 0 to 10 Numerical Rating Scale) during the last 35 days of treatment compared to placebo (43% vs. 10% and 47% vs. 17%, respectively; both p < 0.001). A seventh key secondary endpoint for reduction in fibroid volume was not achieved in either study.

Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2. The overall incidence of adverse events in the relugolix combination and placebo groups were also comparable (62% vs. 66% and 60% vs. 59%, respectively), including hot flashes (11% vs. 8% and 6% vs. 4%, respectively). There were no pregnancies reported in the relugolix combination groups in either study.

“The heavy bleeding and pain that women with uterine fibroids commonly experience can have a significant impact on their everyday lives,” said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “These data offer strong evidence that relugolix combination therapy, if approved, could be an important new oral treatment with the potential to help patients living with this debilitating condition.”

Data from LIBERTY 1 and LIBERTY 2, in addition to the 28-week long-term extension study, were included in the New Drug Application for relugolix combination tablet for uterine fibroids, with an FDA decision expected by the June 1, 2021 target action date. Myovant previously announced results from the LIBERTY long-term extension study in February 2020. At one year, 87.7% of women receiving relugolix combination therapy met the responder criteria. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year. Changes in bone mineral density and the incidence of adverse events were consistent with those in LIBERTY 1 and LIBERTY 2.

PFE


La variante surafricana reduciría la protección dela vacuna

today announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to neutralize SARS-CoV-2 with the South African variant spike protein. This study, which builds on previous work, was conducted by Pfizer and the University of Texas Medical Branch (UTMB), and results were published in the New England Journal of Medicine.

The current in vitro study investigated the full set of South African variant (also known as B.1.351 lineage) spike mutations. To this aim, three genetically engineered recombinant viruses were produced. One virus had the full set of spike glycoprotein mutations found in the South African variant and the other two had subsets of these mutations. The viruses were tested against a panel of sera from 20 participants in the previously reported Phase 3 trial who had been immunized with the Pfizer-BioNTech COVID-19 vaccine.

Although the results indicated a reduction in neutralization of virus with all the South African variant spike glycoprotein mutations, all the sera neutralized all the viruses tested. This finding is consistent with recent reports of the neutralization of variant SARS-CoV-2 or corresponding pseudoviruses by convalescent or post-immunization sera.i,ii

There is no clinical evidence to date that the South African variant virus escapes BNT162b2-elicited protection from COVID-19 in vaccinated people. Nevertheless, Pfizer and BioNTech are taking the necessary steps, making the right investments, and engaging in the appropriate conversations with regulators to be in a position to develop and seek authorization for an updated mRNA vaccine or booster once a strain that significantly reduces the protection from the vaccine is identified.

Pfizer and BioNTech are currently evaluating neutralization of SARS-CoV-2 with the Brazilian strain spike mutations, as well as mutations from other emerging SARS-CoV-2 variants, and they continue to conduct studies to monitor the vaccine’s real-world effectiveness. Pfizer and BioNTech believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to develop new vaccine variants if required.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.


PS:  Salto en after  a 34,90, 10 céntimos por debajo de mi precio por lo que pueda pasar, aunque no sea nada nuevo

XBI

hoy queremos lechugas para confirmar esa vela en soporte

PFE 
Esto se sabe desde que NVAX dio los resultados en SA. No creo que sea noticia para mucha gente...

Yo no entro en ningún listado de vacunación reciente ni por profesión ni por edad *menor de 45 aun no aparecemos en ninguna lista], pero me gustaría que si me toca la de Astra Zeneca me dieran la opción  de donarla a un sanitario de país en vías de desarollo sin opción a vacuna por el momento. Ya he leído que parece que hay algún movimiento al respecto >

Que forma mas amable de decir que se la metan por donde les quepa 🤣

Hoy primer shot a mi mujer, la de Pfizer.
Se ha vuelto a casa, mareos y nauseas.  Y el brazo dormido, sin fuerza.