‘News’ Category

Novel NASH Remedy Will get FDA’s Quick Monitor Designation

HTD1801 is a new molecular entity being developed for NASH and primary sclerosing cholangitis The Food and Drug Administration (FDA) has granted Fast ...

 
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. 

FDA Approves Tumor-Agnostic Oral Most cancers Remedy Vitrakvi

 

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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FDA Approves Venclexta for Therapy of Acute Myeloid Leukemia

 

November 26, 2018

Venclexta (venetoclax) is a BCL-2 inhibitor

Venclexta (venetoclax) is a BCL-2 inhibitor

The Food and Drug Administration (FDA) has granted accelerated approval to Venclexta (venetoclax; AbbVie and Genentech) for the treatment newly-diagnosed acute myeloid leukemia (AML) in patients aged ≥75 years, or for those ineligible for intensive induction chemotherapy due to comorbidities. It is intended for use in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine (LDAC).

The FDA approval was supported by data from the Phase 1b M14-358 dose escalation and expansion study and the Phase 1/2 M14-387 dose escalation and expansion study that included patients with newly-diagnosed AML, including those who were ineligible for intensive induction chemotherapy. In the M14-358 study, the rate of complete remission (CR) was 37% (N=25/67) in the Venclexta + azacitidine group and 54% (N=7/13) in the Venclexta + decitabine group; the rate of complete remission with partial blood count recovery (CRh) was 24% (N=16/67) and 8% (N=1/13) in the Venclexta + azacitidine and Venclexta + decitabine groups, respectively. In the M14-387 study, the data showed the rates of CR and CRh were both 21% (N=13/61) for patients who received Venclexta + LDAC. 

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“Many people with acute myeloid leukemia are unable to tolerate standard intensive chemotherapy, and the Venclexta combination regimens represent important new options for these patients,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.

The conditional approval is based on surrogate endpoints that are reasonably likely to predict a clinical benefit, including CR and CRh. Continued FDA approval for this indication may be contingent upon verification and description of clinical benefit observed in confirmatory trials. 

Venclexta, a BCL-2 inhibitor, is also approved to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, in patients who have received at least one prior therapy, alone or in combination with rituximab. It is available as 10mg, 50mg, and 100mg strength tablets.

For more information call (800) 633-9110 or visit Venclexta.com.

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HCV Reinfection Charges Examined Following Profitable Therapy

 

November 20, 2018

“Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded

“Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded

Reinfection rates of hepatitis C virus (HCV) following treatment with direct-acting antivirals (DAA) were assessed in a large, population-based cohort study presented at The Liver Meeting 2018.

In order to determine HCV reinfection rates following sustained virologic response (SVR) in the overall population as well as in PWID, the study authors analyzed data obtained from a population-based study that included >1.7 million people that were tested for HCV. “We assessed HCV-infected individuals treated with DAAs between 1/1/2014 and 7/1/2017 who achieved SVR and had ≥1 subsequent HCV RNA test for reinfection,” the study authors explained. Reinfection was defined as one positive HCV RNA test following SVR and persistent reinfections were considered in patients who did not spontaneously clear. 

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An algorithm derived from physician diagnosis and hospitalization codes was utilized to assess current (<3 years prior to SVR) and former (≥3 years prior to SVR) PWID. The study authors stated, “Crude reinfection rates per 100 person-years (PYs) were calculated and Poisson regression was used to model age and sex-adjusted incidence rate ratios (IRRs).”

A total of 4,114 patients were included in the study, of which, 21% were current PWID and 44% were former PWID; 5% of PWID reported using opiate agonist therapy (OAT).

The study authors reported that the reinfection rate was calculated to be 1.45/100 person-years (PYs) and 1.19/100 PYs for persistent reinfection. Additionally, higher crude reinfection rates were observed in current PWID (3.1/100 PYs; IRR: 8.0; 95% CI: 2.4, 27) compared to former PWID (1.4/100 PYs; IRR: 4.2; 95% CI: 1.2, 14) and non-PWID (0.3/100 PYs).

Data analysis also found reinfection rates in current PWID to be higher for patients <45 years old compared to those ≥45 years old (10.4/100 PYs vs 2.0/100 PYs, respectively) as well as in male patients compared to female patients (3.8/100 PYs vs 1.7/100 PYs, respectively). The study authors added, “Among PWID, OAT use ≥28 days since completing therapy was associated with a non-significant reduction in reinfection risk (1.5 vs. 2.1/100 PYs, IRR: 0.7, 95% CI: 0.1, 3.3).”

According to the results of this study, HCV reinfection rates appear to be elevated following DAA therapy in PWID. “Interventions to reduce reinfection risks are necessary to prevent ongoing transmission,” the study authors concluded.

Reference

Rossi C, et al, Hepatitis C Virus Reinfection after Successful Treatment with Direct-Acting Antiviral Therapy in a Large Population-Based Cohort. Presented at AASLD The Liver Meeting 2018. Study number 1593.

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Actual-World Information Present Rising HCV Epidemic Amongst Younger Adults

 

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