Right in time for Christmas, FDA approved Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak), and Olaparib (Lynparza)

December 20, 2014 – Right in time for Christmas, the American Food & Drug Admininistration (FDA) on December 19 approved three significant new drugs, namely Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak) and Olaparib (Lynparza), each of which represents a significant  contribution to the therapy options of the targeted patient groups or subgroups.

First of all, FDA approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI). Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI.  Zerbaxa is the fourth new antibacterial drug approved by the FDA this year. The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.

Zerbaxa is the fourth new antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Zerbaxa was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection. As part of its QIDP designation, Zerbaxa was given priority review, which provides an expedited review of the drug’s application. The QIDP designation also qualifies Zerbaxa for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.

Zerbaxa’s efficacy to treat cIAI in combination with metronidazole was established in a clinical trial with a total of 979 adults. Participants were randomly assigned to receive Zerbaxa plus metronidazole or meropenem, an FDA-approved antibacterial drug. Results showed Zerbaxa plus metronidazole was effective for the treatment of cIAI. The efficacy of Zerbaxa to treat cUTI was established in a clinical trial where 1,068 adults were randomly assigned to receive Zerbaxa or levofloxacin, an antibacterial drug approved by the FDA to treat cUTI. Zerbaxa demonstrated it was effective in treating cUTI. The Zerbaxa label includes a warning about decreased efficacy seen in patients with renal impairment. The most common side effects identified in the clinical trials were nausea, diarrhea, headache and fever (pyrexia).

The second drug just approved is Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis. Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which is used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis). Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014. Viekira Pak’s efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis.

In different trials, participants were randomly assigned to receive Viekira Pak or placebo (sugar pill); Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured. Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved SVR. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily. The most common side effects reported in clinical trial participants were feeling tired, itching, feeling weak or lack of energy, nausea and trouble sleeping.

Last but not least FDA also approved Olaparib (Lynparza) as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.   Concurrent with this action, FDA approved the BRACAnalysis CDx (Myriad Genetics) for the qualitative detection and classification of variants in the BRCA1 and BRCA2 genes.

 Ovarian CancerThe approval is based on objective response rate (ORR) from the international, single-arm trial in patients with deleterious or suspected deleterious gBRCAm advanced cancers. The trial enrolled 137 patients with measurable, gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy. Treatment continued until disease progression, unacceptable toxicity, and/or consent withdrawal.  Of the 137 patients, 93% had ECOG performance status of 0 or 1. Deleterious or suspected deleterious gBRCAm status was verified retrospectively in 97% (59/61) of the patients for whom blood samples were available by the companion diagnostic BRACAnalysis CDx. The trial results demonstrated an ORR of 34% (95% CI: 26, 42).  The median response duration was 7.9 months (95% CI: 5.6, 9.6).

 The most common adverse reactions (greater than or equal to 20%) in patients treated with olaparib were anemia, nausea, fatigue (including asthenia), vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngitis/URI, cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash and abdominal pain/discomfort.  Myelodysplatic syndrome and/or acute myeloid leukemia occurred in 2% of the patients enrolled on this trial. The recommended olaparib dose is 400 mg orally twice daily.

Tags: , , , , , , , , , , , ,
About the Author
thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
25 comments on “Right in time for Christmas, FDA approved Ceftolozane/Tazobactam (Zerbaxa), Ombitasvir/Paritaprevir/Ritonavir co-packaged with Dasabuvir (Viekira Pak), and Olaparib (Lynparza)
  1. Hiram says:

    Very informative post, i’m regular reader of your blog. I noticed that your blog is outranked
    by many other blogs in google’s search results. You deserve to be in top ten. I know what can help you, search in google for:
    Kelustu’s tips outsource the work

  2. good website, i am pleased i encountered this blog. Thanks

  3. Anything in daily life may be accomplished by holding on firmly to a certain objective
    even if you will find hindrances towards success. There are a great deal of foods on the market that provide it, so take time to start being active .
    of which into your diet and you’ll be on the right path to losing 10 pounds inside a week.
    You must please remember the kind of foods in this diet are
    extremely limited.

  4. Thank you for another informative web site. The place else could I am
    getting that kind of information written in such an ideal means?
    I’ve a challenge that I am simply now operating on,
    and I’ve been on the look out for such info.

  5. web page this is exactly what i was browsing for Thanks I had to have this

  6. ÿþS says:

    Superb blog! Do you have any helpful hints for aspiring writers? I’m hoping to start my own website soon but I’m a little lost on everything. Would you propose starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m totally overwhelmed .. Any ideas? Kudos!

    • thassodotcom thassodotcom says:

      I, for myself, opted for WordPress on my own hosting company. Other than that, I am not (I do not have the necessary funds) investing to much in paid services. I am dreaming of being funded great time; unfortunately, no investor or donor had the same dream so far.

  7. Excellent post, i surely enjoy this fantastic website,
    keep posting.

    My site – fully automatic office coffee machine

  8. I’m crazy about this blog. I have visited this site so often. I found this website on the search
    engines. I have obtained an excellent stuff of information. Thanks a lot.

    Here is my webpage; dating (http://www.blogigo.com)

  9. You desire to grow your followers and community, spamming people is not
    the method it, end of story. It is very
    important that you take the time to learn the way all these work,
    and just how they are often integrated for your advantage.
    Exact match – using this type, you need to apply the
    square brackets [ ] round the keyword which narrows the search even further.

  10. hey there and thank you for your information –
    I have certainly picked up something new from right
    here. I did however expertise a few technical issues using this site, as I experienced
    to reload the web site many times previous to I could get it to
    load correctly. I had been wondering if your web host is OK?
    Not that I am complaining, but sluggish loading instances times will sometimes affect your
    placement in google and could damage your high-quality score if advertising
    and marketing with Adwords. Well I am adding this RSS to
    my e-mail and can look out for much more of
    your respective exciting content. Ensure
    that you update this again very soon.

  11. You’re so cool! I dont suppose Ive read anything like this before.
    So nice to find any individual with some unique thoughts on this subject.
    truly thank you for starting this up. this website is one
    thing that’s wanted online, somebody with a bit
    of originality. great job for bringing something new to
    the internet!

    Feel free to surf to my page – a1biz (http://www.mapquest.com)

  12. Good site you have got here.. It’s hard to find quality writing like yours these days.

    I honestly appreciate people like you! Take care!!

  13. I pay a visit everyday some websites and sites to read articles or reviews, however
    this webpage gives quality based articles.

    Also visit my web site: Bajar de peso

  14. When someone writes an article he/she maintains
    the idea of a user in his/her mind that how a user can know it.
    Therefore that’s why this article is outstdanding.
    Thanks!

    Feel free to surf to my blog post: kamagra witryna internetowa

  15. I love your blog.. very nice colors & theme. Did you make this website yourself or did
    you hire someone to do it for you? Plz respond as I’m looking to construct my own blog and
    would like to know where u got this from. thank you

    Feel free to visit my web site: colored diamonds

  16. Jason says:

    I need to to thank you for this good read!! I certainly loved every little bit of it.
    I have got you bookmarked to look at new stuff you post…

  17. Kristie says:

    I heard from somking spice that a dude died, currently I
    am a weedhead and somke blunts like its nothing but i wouldn’t recommend any one to roll-up and somke no
    mega20.

    Look at my webpage; glass bongs under 100 (Kristie)

  18. Otis says:

    For latest information you have to pay a quick visit
    the web and on internet I found this web page as a most excellent site for latest updates.

    my blog http://mmlab.snu.Ac.kr/xe/?document_srl=1526894; Otis,

  19. Darla says:

    I was wondering if you ever considered changing the
    layout of your site? Its very well written; I love what
    youve got to say. But maybe you could a little more in the way of content so people
    could connect with it better. Youve got an awful lot of text for only having one or two pictures.

    Maybe you could space it out better?

    My weblog – http://alt7.com.br/?option=com_k2&view=itemlist&task=user&id=130664, Darla,

  20. Everything is very open with a very clear clarification of the challenges.
    It was really informative. Your website is extremely helpful.
    Many thanks for sharing!

  21. Excellent post. I used to be checking continuously this weblog and I’m impressed!
    Extremely useful info particularly the closing section :
    ) I handle such information a lot. I used to be seeking this particular
    information for a long time. Thank you and best of luck.

    Feel free to surf to my webpage; preferred jewelry

  22. be-all says:

    Useful information. Lucky me I found your web site by chance, and I’m shocked why this accident didn’t
    came about earlier! I bookmarked it.

  23. You completed several good points there. I did specific searches
    on the issue and found many individuals can relate with along with your blog.
    Fantastic post!

Leave a Reply

Optional: Social Subscribe/Login




Your email address will not be published. Required fields are marked *

*

thasso: community

thasso: conditions

thasso post: magazine

View my Flipboard Magazine.

thasso: follow us

thasso: chat

You must be a registered user to participate in this chat.

thasso: tweets

thasso: categories

thasso: archives

Top