Novartis receives two new FDA approvals

Novartis announced that the US Food and Drug Administration (FDA) has approved Cosentyx^® (secukinumab) for the treatment of two new indications - adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). AS and PsA are both life-long, painful and debilitating inflammatory diseases that affect the joints and/or spine. If not treated effectively, both conditions can lead to irreversible joint and/or spinal bone damage caused by years of inflammation.

Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors to treat both AS and PsA. The two new indications follow the earlier FDA approval for Cosentyx in January 2015 to treat adult patients with moderate-to-severe plaque psoriasis, and European approval for AS and PsA in November 2015.

In the US, it is estimated that up to 0.5% of the population have AS, and up to 1% live with PsA. If not treated effectively, these conditions can lead to irreversible damage to the spine and joints, causing life-long pain and disability that can have a negative impact on even simple tasks in life. There is an urgent unmet need for new medicines for these conditions. Currently many patients are dissatisfied with their treatments, and up to 40% do not respond sufficiently to anti-tumor necrosis factor-alpha (anti-TNFs) therapy.

Novartis announces efficacy of Cosentyx in ankylosing spondylitis patients

Novartis announced that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in the New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in the signs and symptoms of active AS - a long-term, painful and debilitating inflammation of the spine. Collectively the studies form the largest clinical trial program ever conducted in AS, involving 590 patients.

 

In both studies, the primary endpoint was the proportion of patients with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16 with Cosentyx 150 mg. ASAS 20 response rates with Cosentyx 150 mg vs placebo at Week 16 were 60.8% (vs 28.7%, p<0.001) for MEASURE 1 and 61.1% (vs 28.4%, p<0.001) for MEASURE 2[2]. The studies enrolled anti-tumor necrosis factor (anti-TNF) naïve patients and patients who had previously failed anti-TNF therapy, with clinical benefits demonstrated across the trial populations.

Clinical improvements were seen as early as Week 1 and were sustained throughout the studies, with up to 77% of patients achieving an ASAS 20 response at the end of Week 52. Efficacy assessments, except those at Week 16, were exploratory endpoints.

Cosentyx is the first IL-17A inhibitor to demonstrate efficacy in Phase III AS studies and was recently approved in Europe to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs). New treatment options are needed for patients who do not achieve an adequate response to NSAIDs or anti-TNFs, with up to 40% of patients not responding sufficiently to the latter.

GSK completes divestment rights of ofatumumab to Novartis

GlaxoSmithKline Plc announced the completion of its transaction to divest its rights to ofatumumab for auto-immune indications to Novartis Pharma AG (“Novartis Pharma”), a subsidiary of Novartis AG, following regulatory approval.

The consideration payable by Novartis Pharma to GSK may reach up to $1,034 million and comprises a series of milestone payments as: $300 million paid at closing; $200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis; further contingent payments of up to $534 million payable on the achievement of certain other development milestones.

Novartis Pharma will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications. Income generated from the divestment will be treated as non-core in line with the accounting policies outlined in the third quarter financial results announcement of 28 October 2015.

 

Novartis presents new data on advanced breast cancer

Novartis will present data that highlight advancements in targeted combination therapy research, and underscore the company's continued commitment to bringing innovative treatments to patients living with advanced breast cancer at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), December 8-12. Novartis will present 55 abstracts showcasing key real-world data from Afinitor® (everolimus), Tykerb® (lapatinib) and several investigational compounds in advanced breast cancer.

Because BKM120 (buparlisib), LEE011 (ribociclib), BYL719 (alpelisib) and LA-EP2006 are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of the uncertainty of the outcome/results of the clinical trials, there is no guarantee that BKM120, LEE011, BYL719 and LA-EP2006 will ever be commercially available anywhere in the world.

EU Approves Entresto

Novartis announced that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.

The approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly. As a consequence patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.

Every day 10,000 Europeans are diagnosed with heart failure and 15 million are estimated to live with the condition. Despite the prevalence, most people fail to recognize the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.

Entresto exhibits the mechanism of action of an Angiotensin Receptor Neprilysin Inhibitor that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS)

Novartis presents new two year data for Cosentyx

Novartis announced new results for Cosentyx^® (secukinumab) showing no further progression in joint damage in 84% of patients with psoriatic arthritis (PsA). In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment. These results from the extension phase of the FUTURE 1 study were presented at the 2015 Annual Meeting of the American College of Rheumatology (ACR) in San Francisco, United States. Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to demonstrate efficacy in Phase III studies in PsA - a life-long inflammatory disease that affects the skin and joints. If not treated effectively, it can lead to irreversible joint damage and disability caused by years of inflammation.

New medicines with an alternative way of working are needed as many patients do not achieve an adequate response from current treatments, such as disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatories or anti-tumor necrosis factor (anti-TNF) therapies. Many patients do not respond to or tolerate these therapies, with approximately 45% of PsA patients dissatisfied with their treatments.

Entresto recommended by CHMP for EU approval

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Entresto(TM) (sacubitril/valsartan), marking an important milestone towards becoming available in the EU. Pending final approval by the European Commission (EC) Entresto, previously known as LCZ696, will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction.

The CHMP's decision, which follows previous US and Swiss approvals, is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.

Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly. As a consequence patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life. Even though millions live with heart failure most people fail to recognize the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.

Novartis receives EU approval for Farydak

Novartis announced today that the European Commission has approved Farydak^® (panobinostat, previously known as LBH589) capsules, in combination with bortezomib* and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). The approval of Farydak marks the first time a histone deacetylase (HDAC) inhibitor with epigenetic activity is available in the European Union (EU), providing a new treatment option for patients living with multiple myeloma whose disease has progressed after standard-of-care therapy.

Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. Farydak is the first HDAC inhibitor to show efficacy in multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help restore cell function in patients with multiple myeloma.

Farydak in combination with bortezomib and dexamethasone is also approved in the US, Chile and Japan for certain patients with previously treated multiple myeloma. The exact indication for Farydak varies by country. In the US, Farydak is approved in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an IMiD. Continued approval in the US may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

Novartis receives EU approval for new Revolade

Novartis announced today that the European Commission has approved Revolade^® (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant.

SAA is a blood disorder where the bone marrow does not make enough red blood cells, white blood cells and platelets. Two out of every one million people in Europe are diagnosed with aplastic anemia per year, a portion of which are severe cases. The exact cause of the disease is still unknown, but most cases of SAA are believed to be triggered by an autoimmune reaction where the body attacks blood-forming stem cells located in the bone marrow. As a result, patients with SAA are at risk for life-threatening infections or bleeding. 

Treatment of SAA is focused on increasing the number of healthy cells in the blood (blood cell count). The current standard of care includes IST or hematopoietic stem cell transplantation. Of patients treated with IST, one-quarter to one-third will not respond and 30-40% of responders will relapse, causing symptoms to return. Approximately 40% of SAA patients who don't respond to initial IST die from infection or bleeding within five years of their diagnosis.

The European Commission approval applies to all 28 EU member states plus Iceland, Norway and Liechtenstein. In August of 2014, eltrombopag (marketed as Promacta^® in the USA), was approved by the US Food and Drug Administration for once-daily use in patients with SAA who have had an insufficient response to IST. Eltrombopag is also approved for SAA in Canada.