U.S. Food and Drug Administration (FDA) Has Approved Merck’s (MSD) ZINPLAVA ™ (bezlotoxumab) Injection 25mg/ml To Reduce Recurrence Of Clostridium difficile Infection In Patients 18 Years Of Age Or Older

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Merck  known as MSD outside the United States and Canada, on October 22, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.

Merck anticipates making ZINPLAVA available in first quarter 2017.

ZINPLAVA is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI.

ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI is higher in certain patient populations, including people 65 years of age or older and those with compromised immune systems.

“For generations, Merck has been steadfast in its commitment to fighting infectious diseases – and that commitment continues today. ZINPLAVA is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects,” said Dr. Nicholas Kartsonis, vice president of clinical development, infectious diseases, Merck Research Laboratories.

Selected safety information about ZINPLAVA

Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. Additionally, in patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients [19.5% (23/118)] than in placebo-treated patients [12.5% (13/104)] during the 12-week study period. The causes of death varied, and included cardiac failure, infections, and respiratory failure. In patients with a history of CHF, ZINPLAVA (bezlotoxumab) should be reserved for use when the benefit outweighs the risk.

The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy included nausea (7% vs 5%), pyrexia (5% vs 3%) and headache (4% vs 3%).

Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of ZINPLAVA-treated patients and 1.0% of placebo-treated patients.

In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%) and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% of patients experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.

As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bezlotoxumab in two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. Following treatment with ZINPLAVA in these two studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

About bezlotoxumab

Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and was licensed to Merck in 2009.

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.

For more information, visit www.merck.com

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C Diff Foundation Opens a New Avenue – C. diff. Nationwide Community Support Program

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The C Diff Foundation introduces the                                                                 C. diff. Nationwide Community Support (CDNCS) program beginning in November for patients, families, survivors and for anyone seeking information and support.

C. difficile (C. diff.) infections caused almost half a million infections among patients in the United States in a single year, according to a 2015 study by the Centers for Disease Control and Prevention (CDC).

In addition, an estimated 15,000 deaths are directly attributable to C. difficile infections, making them a substantial cause of infectious disease death in the United States. (See note below [i].)

As of 2015, there is an absence of professional C. diff. (CDI) support groups in America. The                         C Diff Foundation has pioneered a collaborative plan and developed support groups in a variety of availability and locations to meet the needs of individuals seeking C. diff. information and support.

“We found it to be of the utmost importance to implement this new pathway for support and healing after speaking with numerous patients, family members, and fellow-C. diff. survivors,”

The C Diff Foundation now speak for the thousands of patients within the United States who, each year, are diagnosed with a C. diff. infection. This growth, in part, reflects the value C. diff. support groups will provide, not only to patients, their spouses, and families who are living with and recovering from a C. diff. infection, but also to the countless number of individuals who will become more aware of a C. diff. infection, the importance of early detection, appropriate treatments, and environmental safety protocols. There will also be Bereavement support group sessions for  C. diff. survivors mourning the loss of loved ones following their death from C. diff. infection involvement.

Beginning November 2015 the CDNCS groups will be available to all individuals via: Teleconferencing with some groups advancing and adding computer application programs in 2016. CDNCS groups will provide support and information  to 15 participants in each session.

The CDNCS program sessions will be hosted via: Teleconferencing with leaders and fellow C. diff. survivors  from Maryland, Florida, Missouri, Colorado, Ohio, and Oregon.

The Colorado CDNCS group is offered at a public venue and will be hosted in Arvada, Colo. every third Thursday of each month, beginning November 19th. The Meeting will start at 5:30 p.m. and end at 7 p.m lead by a C Diff Foundation Volunteer Advocate and C. diff. survivor  Mr. Roy Poole.

To participate in any CDNCS group being offered during each month, all interested participants will be asked to register through the Nationwide Hot-Line (1-844-FOR-CDIF) or through the  website http://cdifffoundation.org/ where registered individuals will receive a reply e-mail containing support group access information.

  • The Support Registration Page  will be available on November 1st.

The C. diff. Nationwide Community Support group leaders will provide a menu of topics being shared each month on the C Diff Foundation’s website ranging from Financial Crisis Relief, Bereavement, Nutrition, Mental Health, to C. diff. infection updates and everyday life during and after being treated for a prolonged illness. Both Community based sessions and Teleconference sessions will host healthcare profession topic experts

There is evidence that people who attend support group meetings have a better understanding of the illness and their treatment choices. They also tend to experience less anxiety, develop a more positive outlook, and a better ability to cope and adapt to life during and after the treatment for C. diff.

There is a Purpose:

A diagnosis of a C. diff. infection is unexpected and almost always traumatic. As a result, it is not uncommon for newly diagnosed patients to experience a wide range of emotions including, confusion, bewilderment, anger, fear, panic, and denial. Many people find that just having an opportunity to talk with another person, who has experienced the same situation, to help alleviate some of the anxiety and distress they commonly experience.

Individuals also find that they benefit not only from the support they receive, but also from the sense of well-being they gain from helping others. It has been said “support is not something you do for others but rather something you do with others.”

“None of us can do this alone – all of us can do this together.”

Follow the C Diff Foundation on Twitter @cdiffFoundation #cdiff2015 and                                        Facebook https://www.facebook.com/CdiffFoundationRadio.

Note/citation: [i] http://www.cdc.gov/drugresistance/biggest_threats.html

Remembering All C. diff. Survivors With Warm Thoughts and Gratitude In The New Year

2014 is coming to a close and 2015 is just a few hours away.CDIFF2015wordss

 

As the New Year approaches, our thoughts turn gratefully to those who have helped us in our progress and the progress of our communities.  It is in this spirit we say, simply and sincerely,  thank you.

 

 

Thank you for everything big and small you do to help make the C Diff Foundation a better resource in the lives of others, providing support, and for joining us in raising C. diff. awareness to the millions of families, healthcare providers, communities, and friends worldwide.

We are a giving Foundation and a lot of that giving is facilitated through each of you.  Giving makes a difference and there are so many different ways to give.  Whether it is through presentations at a conference,  sharing your journey with others, joining the Foundation’s volunteer program, or donating time in November for the “Raising C Diff Awareness” campaign in communities across the globe the partnered efforts and contributions are greatly appreciated. Through the many facets of giving and charitable support, the Foundation’s mission continues to move forward in educating, and advocating for C. diff. prevention, treatments, and environmental safety worldwide.

From all of us to all of you and your families,  we send our best wishes for a peaceful, happier, healthier, and successful 2015!

Thank you and Happy New Year.

C. diff. Survivors Alliance Network Officially Launched

 

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The C. diff. Survivors Alliance Network, an affiliate of the C Diff Foundation,  is dedicated for providing healing support for individuals coping with both physical and mental pain, the complex treatments, psychosocial losses and alterations, and the excruciating grief with complex emotions that accompany the loss of a loved one.
 
We hope that you will find resources here to help you cope with, and eventually heal from, what may well be the worst pain experienced from an infection.