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FDA: MS Drug Linked to Circumstances of Stroke, Blood Vessel Wall Tears

Posted in News on 30th November 2018
Most cases occurred within 1 day of receiving Lemtrada

Most cases occurred within 1 day of receiving Lemtrada

The Food and Drug Administration (FDA) has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with multiple sclerosis (MS) shortly after receiving Lemtrada (alemtuzumab; Sanofi Genzyme). Alemtuzumab, a monoclonal antibody, is also approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath (alemtuzumab; Sanofi Genzyme).

Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada; 1 patient who suffered a hemorrhagic stroke died. Most cases (12/13) occurred within 1 day of receiving Lemtrada; 1 patient reported symptoms 3 days after starting treatment. While the etiology is unknown, the adverse events appear to have occurred within the same time frame as cytokine release syndrome, an inflammatory response associated with Lemtrada use. Reports of ischemic stroke and intracerebral hemorrhage have also been documented in patients treated with Campath for B-cell CLL and other leukemias/lymphomas.

The prescribing information and Medication Guide for Lemtrada have been updated with a new warning to reflect these risks. In addition, the risk of stroke has been added to the existing Boxed Warning. The Campath drug labeling has also been updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Healthcare professionals should advise patients at each infusion to seek medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. Patients who complain of symptoms suggestive of these conditions should be promptly evaluated.

New antibody can scale back swelling assaults in sufferers with hereditary angioedema

Posted in News on 29th November 2018

Sufferers with hereditary angioedema expertise recurrent and generally life-threatening swelling assaults. Researchers from Charité – Universitätsmedizin Berlin have examined an antibody able to lowering the frequency of those swelling assaults by greater than 90 p.c. Outcomes from their part three trial had been revealed yesterday in JAMA, the famend Journal of the American Medical Affiliation.

Hereditary angioedema is a uncommon genetic illness characterised by painful swellings affecting the pores and skin, mucous membranes and inner organs. Assaults happen spontaneously and often final for a number of days. Swelling of the higher airways together with the throat and tongue could cause loss of life by asphyxiation. In severely affected sufferers, therapy often entails prophylactic remedy geared toward lowering the chance of life-threatening swelling. Up to now, therapies accessible for this objective usually produced extreme unwanted side effects, required a number of injections per week, or had been of restricted efficacy.

Charité-based researchers have now been in a position to present that lanadelumab, a brand new monoclonal antibody therapy, is able to lowering the frequency of swelling assaults by greater than 90 p.c. Given each two weeks by subcutaneous injection, the therapy could be self-administered by the affected person utilizing an injection pen. “This new antibody is the simplest therapy at present accessible for the prevention of swellings in sufferers with hereditary angioedema,” explains Prof. Dr. Marcus Maurer, Analysis Director of Charité’s Division of Dermatology, Venereology and Allergology and senior creator of the examine. “It is going to additionally come as an awesome aid to sufferers that this medication solely must be injected as soon as each two weeks,” he provides.

As a part of their worldwide part three trial, 125 sufferers aged 12 years or older obtained completely different dose regimens of lanadelumab or placebo for a length of 26 weeks. At the simplest dose, the antibody-based therapy lowered the month-to-month assault charge from three.5 to zero.26. Based mostly on the outcomes of this trial, the European Medicines Company’s Committee for Medicinal Merchandise for Human Use really helpful in October that lanadelumab be licensed to be used within the prevention of recurrent assaults of hereditary angioedema in sufferers aged 12 years and older. “This suggestion will inform the European Fee’s determination on a advertising authorization, which is anticipated later this 12 months,” says Prof. Maurer.

Lanadelumab is an antibody that targets a protein within the physique known as kallikrein. Within the bloodstream, kallikrein produces bradykinin, a tissue hormone that causes fluids to leak from blood vessels into tissues, inflicting swelling. In folks with hereditary angioedema, genetic modifications end in an overactivation of the kallikrein system. Lanadelumab binds kallikrein, thereby inhibiting the manufacturing of bradykinin and stopping the swelling assaults sometimes related to the illness.



Novel NASH Remedy Will get FDA’s Quick Monitor Designation

Posted in News on 29th November 2018
HTD1801 is a new molecular entity being developed for NASH and primary sclerosing cholangitis

HTD1801 is a new molecular entity being developed for NASH and primary sclerosing cholangitis

The Food and Drug Administration (FDA) has granted Fast Track designation to an investigational drug for the treatment of nonalcoholic steatohepatitis, or NASH. 

HTD1801 is a new molecular entity being developed for NASH as well as primary sclerosing cholangitis (PSC) by HighTide Therapeutics. The Company has completed a first in human study in healthy volunteers; a Phase 2 trial in adults with NASH is due to begin soon in the US. A multicenter Phase 2 trial in adults with PSC is currently ongoing.

“HTD1801, a multifunctional oral therapeutic, was designed to address the complex nature of NASH, especially for patients with comorbid diabetes and/or dyslipidemia,” said Liping Liu, PhD, CEO of HighTide. 

The Agency has already granted Orphan Drug and Fast Track designation for the PSC indication. 

Drug Presentation for fifth hour well being class

Posted in Sertaline on 29th November 2018

FDA Approves Tumor-Agnostic Oral Most cancers Remedy Vitrakvi

Posted in News on 28th November 2018

November 27, 2018

Vitrakvi is a first-in-class oral TRK inhibitor

Vitrakvi is a first-in-class oral TRK inhibitor

The Food and Drug Administration (FDA) has granted accelerated approval for Vitrakvi (larotrectinib; Bayer and Loxo Oncology) for the treatment of patients with solid tumors that have neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This approval is based on overall response rate (ORR) and duration of response (DOR); continued approval may be based upon verification and description of clinical benefit in confirmatory trials. 

Vitrakvi, a first-in-class oral TRK inhibitor, is also the first agent to receive a tumor-agnostic indication at the time of approval. NTRK gene fusions have been shown to promote cell proliferation and survival in tumor cell lines. By inhibiting these proteins, Vitrakvi has shown efficacy for various tumor types, including lung, thyroid, melanoma, GIST, colon, soft tissue sarcoma, salivary gland, and infantile fibrosarcoma. TRK fusion cancers are diagnosed through specific tests, including those that use next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH). 

Vitrakvi was evaluated in the Phase 1 adult trial, Phase 2 NAVIGATE trial, and the Phase 1/2 pediatric SCOUT trial (N=55). Pooled data showed an ORR of 75% (95% CI, 61%, 85%) among patients treated with Vitrakvi, with 22% of patients having a complete response (CR) and 53% having a partial response (PR) across various tumor types. 

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Of the responders, 73% had a DOR of ≥6 months at the time of data cut-off; median DOR and progression-free survival (PFS) was not reached at the time of analysis. The median time to response was reported to be 1.84 months. 

Regardless of attribution, the most common adverse events (≥20%) were increased ALT/AST, anemia, fatigue, nausea, dizziness, cough, vomiting, constipation, and diarrhea. The majority of adverse events seen in ≥10% of patients were grade 1 or 2.

Vitrakvi will be available as 25mg and 100mg capsules in 60-count bottles, as well as a 20mg/mL oral solution. Vitrakvi will be commercially available immediately. 

For more information call (888) 842-2937 or visit Vitrakvi.com.

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