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FDA approves Collagenase Clostridium Histolyticum for Cellulite

The FDA has approved collagenase clostridium histolyticum for the treatment of moderate to severe cellulite in the buttocks of adult women. The drug is the first injectable treatment for cellulite to receive regulatory approval.

Dose: 0.9mg Solution, Injection

MOA: When injected into the treatment area, It is thought to release the fibrous septae enzymatically by specifically targeting types 1 and 3 collagen, which may result in the smoothing of the skin and an improved appearance of cellulite.

Common side effects: Injection site bruising, pain, areas of hardness, itching, redness, discoloration, swelling, and warmth in the treatment area.

In cellulite, fibrous septae are a primary contributing factor. The septae make up the fibrous connective tissue that connects the skin perpendicularly to the fascia below and tether the skin, drawing it downward and leading to a mattress-like appearance, commonly referred to as “dimpling.”

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Cutaneous manifestations of COVID-19

Observed COVID-19 associated skin patterns were:

Acral erythema with vesicles or pustules; so-called “pseudo-chilblains” or “COVID Toes” (19%)
Vesicular (chicken pox-like) eruptions (9%)
Maculopapular eruptions (47%)
Urticaria (19%)
Livedo or necrosis (6%)

1. Acral areas of erythema-oedema with some vesicles or pustules (pseudo-chilblain) (19% of cases).

These lesions, affecting hands and feet, may resemble chilblains (small, itchy swellings on the skin) with small red or purple spots, caused by bleeding under the skin. They were usually asymmetrical.

Associated with: younger patients, lasted for a mean of 12.7 days, took place later in the course of the COVID-19 disease and was associated with less severe disease (in terms of hospital admission, pneumonia, intensive care unit admission or mortality). They could cause pain (32%) or itch (30%).

2. Other vesicular eruptions (9%).

Vesicular eruptions are outbreaks of small blisters, some of these presented on the trunk. They may also affect the limbs, may be filled with blood, and become larger or more spread out.

Associated with: middle aged patients, lasted for a mean of 10.4 days, appeared more commonly (15%) before other symptoms and were associated with intermediate severity. Itching was common (68%).

3. Urticarial lesions (19%):

These consist of pink or white raised areas of skin resembling nettle rash, known as wheals (also spelled weals), which are usually itchy. Mostly distributed in the trunk or spread across the body. A few cases were on the palms of the hands. Associated with: see below ‘4. Other maculopapules’

4. Other maculopapules (47%).

Maculopapules are small, flat and raised red bumps. In some cases these were distributed around hair follicles, there was also varying degrees of scaling. Some had been described as similar to pityriasis rosea, a common skin condition. Blood spots under the skin may also be present, either in the form of spots/dots or on larger areas.

Associated with: lasting for a shorter period (6.8 days mean for urticarial and 8.6 for maculopapular), usually appeared at the same time than the rest of the symptoms and were associated with more severe COVID-19 disease (2% mortality in the sample). Itching was very common for urticariform lesions (92%) and 57% for maulopapular.

5. Livedo or necrosis (6%).

Livedo is a skin condition where circulation in the blood vessels of the skin is impaired. It causes the skin to take on a blotchy red or blue appearance with a retiform (net-like) pattern. Necrosis refers to the premature death of skin tissue. These patients showed different degrees of lesions suggesting occlusive vascular disease, where a narrowing or blocking of arteries occurs, limiting blood flow to certain areas of the body (in this case the trunk or extremities).

Associated with: older patients with more severe disease (10% mortality). However, the manifestations of COVID-19 in this group were more variable, including transient livedo, with some suffering COVID-19 that did not require hospitalisation.

Source: Medscape, skinhealthinfo.org.uk

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Triple therapy for COPD

Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β2-agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single-dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking.

Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate–formoterol or budesonide–formoterol.

Case study: The modified intention-to-treat population comprised of 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg–budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg–budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate–formoterol group (2120 patients), and 1.24 in the budesonide–formoterol group (2131 patients). The rate was significantly lower with 320-μg–budesonide triple therapy than with glycopyrrolate–formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide–formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P=0.003). Similarly, the rate was significantly lower with 160-μg–budesonide triple therapy than with glycopyrrolate–formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide–formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P=0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate–formoterol group

Source: NEJM.org

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WHO warns of oxygen shortage as COVID cases set to 10 million

The world faces a shortage of oxygen concentrators as the number of worldwide cases of coronavirus infection nears the 10 million. COVID-19 Tracker ›

“Many countries are now experiencing difficulties obtaining oxygen concentrators,” WHO Director General Tedros Adhanom Ghebreyesus told a news conference. “Demand is currently outstripping supply.”

The sudden rise has created a dearth of oxygen concentrators needed to support breathing of COVID-19 patients suffering from respiratory distress.

The health agency has purchased 14,000 oxygen concentrators from manufacturers and plans to send them to 120 countries in coming weeks, Tedros said. A further 170,000 concentrators – valued at some $100 million – will be potentially available over the next six months.

The head of the WHO emergencies programme, Dr Mike Ryan, meanwhile said the pandemic in many Latin American countries was still intense as deaths in the region surpassed 100,000 this week. Many countries had experienced 25-50% increases in cases in the past week, he said.

Source: Reuters

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Gilead prices Remdesivir at $2,340 for a five-day treatment

Gilead Sciences Inc has priced its COVID-19 drug candidate remdesivir at $2,340 for a five-day treatment in the United States and some other developed countries, potentially reflecting looming competition from a cheap steroid.

Remdesivir is at the forefront of the fight against COVID-19 after the anti-viral treatment helped shorten hospital recovery times in a clinical trial. It has been approved for emergency use in some patients in the United States.

The remdesivir price for U.S. private insurance companies will be $520 per vial, Gilead said, which equates to $3,120 per patient for a treatment course of six vials.

Gilead has linked up with generic drugmakers based in India and Pakistan, including Cipla Ltd and Hetero Labs Ltd, to make and supply remdesivir in 127 developing countries.

Cipla’s version is priced at less than 5,000 Indian rupees ($66.24), while Hetero Lab’s version is priced at 5,400 rupees.

Source: Medscape

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FDA approves atezolizumab + bevacizumab for advanced HCC

The US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, it may enable the activation of T-cells.

Bevacizumab is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. It is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasis).

Source: Roche, fda.gov

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Major breakthrough in coronavirus treatment

Dexamethasone ‘Major Breakthrough’ in coronavirus treatment

Dexamethasone reduces deaths by up to a third in hospitalised patients with severe respiratory complications of COVID-19, the University of Oxford’s, UK randomised recovery trial has found.

“It is a major breakthrough,” Co-Chief Investigator, Peter Horby, professor of emerging infectious diseases in the Nuffield Department of Medicine, told a news briefing. “The results are sufficiently clear, we can announce the results today and people could be treated this evening or tomorrow.”

A total of 2104 patients were randomised to receive dexamethasone 6mg once per day by mouth or by intravenous injection for 10 days and were compared with 4321 patients randomised to usual care alone.

Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021). There was no benefit among those patients who did not require respiratory support (1.22 [0.86 to 1.75; p=0.14). Government Chief Medical Adviser Professor Chris Whitty called it “the most important trial result for COVID-19 so far”.

The World Health Organization (WHO) also said that initial clinical trial results from Oxford University showed dexamethasone, a steroid, to be lifesaving for critically ill covid-19 patients.

Source: Medscape

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Ankit Bharat MD performs 1st lung transplant for COVID-19 patient

A woman in her 20s received a double-lung transplant last week after the coronavirus damaged her respiratory system, Northwestern Medicine in Chicago.

The woman spent 6 weeks in the hospital’s COVID ICU on a ventilator and life support. In early June, her lungs developed irreversible damage, and she was listed for a double transplant. Within 48 hours, the team was able to perform the procedure.

“A lung transplant was her only chance for survival,” Ankit Bharat, MD, chief of thoracic surgery and surgical director of the hospital’s lung transplant program, said in the news release. Organ transplants may become more common in severe cases of COVID-19, Ankit Bharat. The coronavirus affects the lungs most often, but it can also damage the heart, kidneys, blood vessels, and nervous system.

“We want other transplant centres to know that while the transplant procedure in these patients is quite technically challenging, it can be done safely,” he said. “It offers the terminally ill COVID-19 patients another option for survival.” The patient tested negative for COVID-19 before she was placed on the transplant list.