FDA Approves Beigene’s Brukinsa for Mantle Cell Lymphoma

The United States Food and Drug Administration (FDA) has granted approval to Brukinsa (Zanubrutinib). A blood cancer drug from Chinese company, BeiGene, giving access to Americans to a Chinese cancer therapy for the first time.

This is an important FDA approval since Mantle cell lymphoma (MCL) is a rare and very aggressive type of non-Hodgkin lymphoma mostly suffered by men over the age of sixty years. And it’s said that about three thousand to four thousand are diagnosed every year t in the United States. This explains why the Food and Drug Administration (FDA) has been working effortlessly to improve outcomes for patients battling with it worldwide and not just United States alone.

This new Bruton tyrosine kinase inhibitor known as Zanubrutinib is a small molecule that works by forming a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of Bruton tyrosine kinase activity. It is an important treatment option for people with refractory mantle cell lymphoma (MCL) who had received other therapies earlier.

The FDA relied largely on clinical trial data generated outside the US for the approval. According to the company, the treatment was tested on 118 patients, 10-15 per cent of whom were from the US. The approval was based on data from a single-arm, open-label, multicenter phase 2 trial that evaluated the safety and efficacy Brukinsa in 86 patients with MCL who had received at least one earlier treatment or therapy. From the analysis, it was noted that Brukinsa triggered an overall response rate of 84% with a median duration of response of 19.5 months. While on the other hand, a complete response was observed in 59% of affected persons and 24% of others achieved a partial response.

Although, Brukinsa is the first BeiGene-discovered drug to be approved by US FDA for her citizens, it is expected to be the first of many approvals for Brukinsa as researchers continue to evaluate its potentials in other hematologic cancers. Today, BeiGene becomes the first FDA green light and first BeiGene-discovered cancer drug in China. And with plans to launch Brukinsa soon, BeiGene will surely be competing with similar blood therapies like Johnson & Johnson and AbbVie’s Imbruvica, AstraZeneca’s Calquence, and Celgene’s Revlimid. It will be interesting to see who emerges top from the healthy rivalry. Beigene, has maintained that it expects to see another one of its cancer drugs very soon, and is equally running a confirmatory phase 3 trial for patients who are not fit for stem cell transplantation.

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AnaptysBio’s Eczema Drug Fails to Meet Phase II Endpoints

AnaptysBio, Inc. is a clinical-stage biotechnology company that is developing its first in class antibody products that are focused on the unmet medical needs in inflammation. It announced the top-line data from its ATLAS trial

This trial was a Phase 2b randomized, placebo-controlled, double-blinded, multi-dose study in approximately 300 adult patients treated with etokimab from moderate-to-severe atopic dermatitis. 

As a result of this trial, each one of the etokimab dosings failed to fulfil the primary endpoints of the trial that included the demonstration of a statistically great improvement in the Eczema Area and the Severity Index (EASI) relative placebo at week 16. 

The company will now be receiving more details and a plan so that they can provide an update later next year in the first quarter. 

As of now, they have decided to postpone the initiation phase of the Phase 2b etokimab’s clinical trial in eosinophilic asthma, until they get the opportunity to be able to analyze the complete data set from the ATLAS trial fully. 

The Company will, however, continue conducting its ECLIPSE trial which is a randomized, placebo-controlled Phase 2 trial on approximately 100 patients(adults) suffering from chronic rhinosinusitis with the top-line data from an interim analysis that is expected to be done in the first quarter of 2020.

President Hamza Suria’s comments about the trial:

Here’s what the President and the chief executive officer of AnaptysBio, Hamza Suria has to say about this trial;

“We are surprised and very disappointed by the top-line results of the ATLAS trial.” He also added; “We would like to thank all involved in the participation and support of the ATLAS study, including the patients, the investigators, their staff and our employees. We look forward to continuing our strategy of advancing our wholly-owned clinical and preclinical pipeline programs.” 

About AnaptysBio’s eczema drug:

The drug anti-IL-33 antibody used for the treatment of eczema initially cleared the mid-stage study in asthma last year but later failed to pass the phase 2b trial testing in eczema or atopic dermatitis.

It did a worse job at easing symptoms like skin itching or inflammation than even placebo even after 16 weeks of continuous treatment, and due to this, it’s stock tanked more than 70% in the pre-market trading.

According to ClinicalTrials.gov, the ATLAS study performed on the drugs took four doses of etokimab against placebo in 300 adult patients of eczema in their moderate to severe eczema, and all four of these doses missed the primary phase II endpoint.

The drug put up some proof data in peanut allergy but later as questions about the size of the study and about its authenticity were raised, the indication was removed from the company’s page.

This is all there is at this stage. However, more information is expected to come out next year, in the fall of 2020, as the company is expected to conduct further analysis on the complete data.

Roche’s Tecentriq is Looking Good with Two More Drug Approvals in Europe

Treatment for cancer patients has come a long way in the past fifty years. Gone are the days when decisions were made based on a hit-or-miss response; the 21st century has enabled us actually to view what’s going inside the body in real-time.

The frontrunner for treating patients, which include medications and therapies, is a drug that goes by the name of Tecentriq. 

What is Tecentriq? 

Tecentriq is a medicinal drug, categorized as a monoclonal antibody, which helps improve our immune system. They fight against the growth of tumour cells.

The main reasons Tecentriq is used for cancer treatment is because it can effectively eliminate cells without any damage to the host. Generally speaking, Tecentriq is given in dosage when cancer has spread from the source to other parts of the body.

As of yet, Tecentriq has been used as a treatment for bladder cancer, urinary tract cancer, and non-small cell lung cancer.

This drug was synthesized in the labs of Roche Holding AG, a pharmaceutical company based out of Switzerland.

Recently, the European Commission granted marketing authorization and permission for Roche Pharmaceuticals. Within the week, the shares of the establishment have rallied up to 12.5%, which is a great number, as opposed to the industry’s growth which is speculated at just 3.3%. 

Approvals in the EU 

Just last week, Roche was given the green light by the relevant authorities to start using their product as the primary treatment for cancer patients. This will be executed in conjunction with chemotherapy. Till last year, another drug was employed as well (Avastin). However, it was shown that the former alone could make a difference in the long run.

This move, in the long run, will pave the way for Roche to establish a new market for themselves. Along with Tecentriq, Roche also plans to promote and regulate the use of two more drugs that aren’t that well known: Hemlibra, which is used for the treatment of Hemophilia, and Ocrevus, which is used for the treatment of multiple sclerosis.

What lays ahead?

Even though the competition is stiff and plenty, there are many underlying facts which point towards Roche’s success in dominating the market in the near future.

As of yet, Roche is working with nine different studies which plan to highlight and signify how Tecentriq can work best to treat cancer patients. They have a big enough sample size and aim to see if Tecentriq works best alone or in conjunction with different medications.

Tecentriq sales have also spiked in the US, Japan, and most of Europe. With this approval, however, sales of Tecentriq are bound to go through the roof since it will now be backed by the EU for multiple markets.

Abbvie’s New Blockbuster Drug For Rheumatoid Arthritis

AbbVie has recently made headlines owing to various different ventures that it has been making in the pharmaceutical community. Whether it is introducing new drugs or antibiotics to the medical industry, or investing in collaborations with other pharmaceutical companies, AbbVie has definitely established itself as a pioneer in several medical fields. In recent news, AbbVie has received official approval by the FDA for their brand new drug, Rinvoq. This drug mainly aims to treat adults with early/late onset, moderate to severe forms of Rheumatoid Arthritis (RA). The exact details and recommended dosage etc. can be found in the sections below. 

What is Rinvoq? 

For starters, Rinvoq is a drug designed to combat Rheumatoid Arthritis. It has been optimized for patients who have experienced or reported inadequate responses from other drugs such as Methotrexate based ones. This includes the pool of patients who are intolerant to the aforementioned drugs, and so Rinvoq has appeared on the scene. Distribution of Rinvoq is expected to start in August this year to pharmaceutical companies all over the United States. 

Rinvoq has been in the works for quite a while. It is part of the FDA’s SELECT program campaign that has recently undergone three different phases of approval for the treatment of RA. Clinical trials have been held by housing over forty thousand under analysis on a nationwide scale. These trials and studies have taken into account patient histories with particular attention to Methotrexate based drugs to the treatment of RA specifically. 

Image via AbbVie

How does it work? 

While Rinvoq is a relatively new venture as compared to its predecessor Humira, AbbVie hopes that it will leave a mark as well. Now, patients who have undergone trials with Rinvoq have been reported to be in clinical remission ever since the start of treatment. Although some of these patients were thought to be under the placebo effect, most did accurately report having achieved remission around the twelve-week mark. This clinical remission supposedly lasts till the twenty-four or twenty-six-week mark. Some side effects of Rinvoq, however, may be a source of alarm because they entail a wide range of lung tract infections that may even prove fatal in the long run. 

Future Prospects for Rinvoq

Aside from the work that needs to be done to improve upon potential side effects and setbacks from the Rinvoq treatment, AbbVie is also looking forward to releasing another brand new drug into the market not too far into this year. With approvals for such drugs by the FDA, the pharmaceutical industry can definitely hope for more improvements and new treatments in order to help more patients that are ailing with disorders much like RA itself. 

Conclusion

With cases of Rheumatoid Arthritis riddling a large chunk of the adult population in the United States, a drug such as Rinvoq has been long overdue, and AbbVie has indeed taken the time to perfect it and present it to the public such that they reap the benefits in the long term.

Will AbbVie will win the market share for Rheumatoid Arthritis? Comment your thoughts!

Bluebird Bio’s Zynteglo Starts at $1.77 Million, Another Gene Therapy Shattering a Million Dollars

Bluebird Bio’s new gene therapy for a rare blood disorder will sell for $1.77 million in Europe. Another gene therapy shattering the million-dollar mark, but shy of Novartis’ $2.1 million-dollar price tag. We’ve arrived in an era where million-dollar gene therapies are the new norm, as drug prices keep climbing higher and higher.

Bluebird received conditional marketing approval by the European Union for Zynteglo. This will be the 2nd most expensive drug therapy to be approved in the world according to The Wall Street Journal. In a press conference, Bluebird Bio announced the price tag and the payment plans for their new drug. Blue bird will have a 5-year payment plan allowing insurers and patients to pay $354,000 a year. Not everyone is a fan of a pay as you go payment plan, investors have drawn concerns about whether Bluebird will ever reach the price set for Zynteglo. Since many biotechnology and pharmaceutical companies are facing pressure from regulations in the EU, a pays as you get better plan is not going to guarantee them the $1.77 million they are asking for their gene therapy.

Although investors are worried about their payment plan, data presented from Bluebird’s poster, Long-Term Efficacy and Safety Data from Clinical Studies of LentiGlobin® Gene Therapy for Transfusion-Dependent β-Thalassemia (TDT) at 24th European Hematology Association (EHA) Congress indicated long term improvements from patients taking Zynteglo. Data present at this conference indicates that patients continue to see benefits after a year. Where one questions whether is there a risk to have a payment plan?

Transfusion-dependent beta-thalassemia is a disease that slows or stops the production of Beta-globin, a component of hemoglobin. Mutations in the beta-globin gene (HBB) makes it difficult for hemoglobin to carry oxygen throughout their body, leading to anemia, fatigue, and other complications coming from too much iron. A problem that blue bird has essentially resolved for patients suffering from a mutation in their HBB gene.

The next question that we face is how will Blue Bird Bio price their gene therapy in the US market. They still haven’t filed a New Drug Application to the Federal Drug Administration, leaving us to wonder whether they will match it with Novartis’ gene therapy?

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